Are there any documented memory faults with the Glucometer Elite XL?
Specifically, has a blood glucose reading ever failed to be entered
into the machines memory? |
Request for Question Clarification by
pafalafa-ga
on
01 Mar 2004 05:12 PST
All told, there have more than 100 reports to the FDA over the past
few years of potential problems with the Glucometer Elite XL.
However, there are several manufacturers associated with the same
machine (I'm not clear why this is). The FDA lists the Glucometer
Elite XL as manufactured by Bayer, Arkray, Baxter, and KDK Corp.
Only two of the reports pertain to a Bayer unit...most of the others
are for the Arkray Glucometer Elite XL.
If you'd like, I can post information about accessing these reports as
an answer to your question. However, I can tell you that the two
Bayer reports deal with possible false readings, rather than the type
of memory problem you describe.
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Clarification of Question by
ymr-ga
on
01 Mar 2004 06:35 PST
I work as a Staff Nurse and use the Glucometer Elite XL machine to
record patients blood sugar levels. Currently I am under
investigation as to whether I falsified a patients record by
documenting a reading that I did take but that subsequently did not
show up in the memory of the Glucometer Elite XL machine which the
hospital obtained from Bayer.Bayer state that this is impossible. I
feel that no machines are completely infallible and was wondering if
there is any information available to support my case as I face a very
real danger of losing my job.
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Request for Question Clarification by
pafalafa-ga
on
01 Mar 2004 07:56 PST
I'm sorry to hear about your difficulties at work, and I hope we can
provide some information that will be useful to you.
From reviewing FDA records on the Glucometer Elite XL, it appears that:
--the meter, distributed by Bayer, is most likely manufactured in
Japan by a company called Arkray
--there are more than 100 reports of meter problems in 2002-2003,
although none that I saw that were specific to the memory.
--the most common problem appears to be misleading readings caused my
missing display elements (that is, not all the LED's on the display
light up as they are supposed to)...have you considered the
possibility that the meter gave you an incorrect reading (that is, you
saw and properly recorded one number, but an entirely different number
was recorded in memory).
--Some fairly typical problem reports look like this:
==========
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 09/08/2003 MDR TEXT KEY: 1678413 Patient Sequence Number: 1
CONTACT STATED THAT THE METER WOULD NOT COUNT DOWN. A REVIEW OF THE
SYSTEM WAS PERFORMED OVER THE PHONE. THIS REVIEW INDICATED TAHTA
SEGMENTS WERE MISSING FROM THE DISPLAY AND THAT THE METER IS NOT
OPERATING AS IT IS INTENDED. THE CUSTOMER WAS ASKED TO RETURN THE
METER FOR FURTHER EVALUATION AND A REPLACEMENT METER WAS PROVIDED. THE
CUSTOMER WAS INVITED TO CAL 24/7 WITH FUTURE QUESTIONS/CONCERNS.
ADDITIONAL MANUFACTURER NARRATIVE
REPORT DATE: 09/08/2003 MDR TEXT KEY: 1678414
UPON REQUEST, PERFORMANCE TESTING WAS CONDUCTED. TESTING DETERMINED
THAT THE METER HAD A BATTERY THAT WAS INCORRECTLY INSERTED INTO THE
METER CAUSING THE DISPLAY TO BE FAINT. WHEN THE BATTERY WAS REPLACED,
THE METER FUNCTIONED ACCORDING TO SPECIFICATIONS. THE COMPLAINT COULD
NOT BE DUPLICATED WITH THE BATTERIES INSERTED AS INTENDED. THIS
COMPLAITN IS CONSIDERED CLOSED FOR PURPOSES OF MDR
==========
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 09/08/2003 MDR TEXT KEY: 1678423 Patient Sequence Number: 1
CUSTOMER STATED PROBLEM WITH THEIR METER. ONLY ABLE TO SEE HALF OF THE
NUMBERS. BATTERIES WERE RECENTLY REPLACED. A REVIEW OF THE SYSTEM WAS
CONDUCTED OVER THE PHONE. THE REVIEW INDICATED THAT THE METER WAS
MISSING SEGMENTS IN THE 100S, 10S AND UNITS POSITIONS OF THE DISPLAY.
THE CUSTOMER WAS ASKED TO RETURN THE METER FOR FURTHER EVALUATION AND
A REPLACEMENT METER WAS PROVIDED. THE CUSTOMER WAS INVITED TO CALL
24/7 WITH FUTURE QUESTIONS/CONCERNS.
==========
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 08/25/2003 MDR TEXT KEY: 1672474 Patient Sequence Number: 1
CUSTOMER STATED THAT THE METER SOMETIMES SHUTS ITSELF OFF AND
SOMETIMES TURNS ITSELF ON. THE CUSTOMER HAS REPLACED THE BATTERIES AND
THE METER STILL IS NOT FUNCTIONING PROPERLY. A REVIEW OF THE SYSTEM
WAS PERFORMED OVER THE PHONE. THE REVIEW DETERMINED THAT THE METER WAS
SHUTTING OFF PREMATURELY AND THAT THE DISPLAY WAS MISSING SEGMENTS IN
THE 100S POSITION. THE CUSTOMER WAS ASKED TO RETURN THE METER FOR
FURTHER EVALUATION AND A REPLACEMENT WAS PROVIDED. THE CUSTOMER WAS
INVITED TO CALL 24/7 WITH FUTURE QUESTIONS/CONCERNS.
==========
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 08/25/2003 MDR TEXT KEY: 1670514 Patient Sequence Number: 1
CUSTOMER'S METER WAS MISSING SEGMENTS. A REVIEW OF THE SYSTEM WAS
PERFORMED OVER THE PHONE. THE REVIEW INDICATED THAT SEGMENTS WERE
MISSING BUT WAS UNABLE TO IDENTIFY WHICH SEGMENTS. THE CUSTOMER WAS
ASKED TO RETURN THE METER FOR FURTHER EVALUATION AND A REPLACEMENT WAS
PROVIDED. THE CUSTOMER WAS INVITED TO CALL 24/7 FOR FUTURE
QUESTIONS/CONCERNS.
ADDITIONAL MANUFACTURER NARRATIVE
REPORT DATE: 08/25/2003 MDR TEXT KEY: 1670515
UPON RECEIPT OF THE METER, PERFORMANCE TESTING WAS CONDUCTED. TESTING
DETERMINED THAT THE METER WAS NOT FUNCTIONING ACCORDING TO
SPECIFICATIONS. NO SEGMENTS WOULD DISPLAY. THE COMPLAINT WAS
CONFIRMED. A ROOT CAUSE ANALYSIS WILL BE PERFORMED ON THIS METER. IF
ANYTHING OF SUBSTANCE IS DETERMINED FROM THIS ANALYSIS, IT WILL BE
FORWARDED TO THE AGENCY FOR REVIEW. THIS COMPLAINT IS CONSIDERED
CLOSED FOR PURPOSES OF MDR.
==========
If you think it would be useful, I can post an answer to your question
that would direct you to all 100+ problem reports for the Glucometer
Elite XL unit, so you could review them in detail.
Let me know how you would like me to proceed on this. And good luck.
pafalafa-ga
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Clarification of Question by
ymr-ga
on
01 Mar 2004 23:53 PST
This problem is specific to memory failure only as the machine was
checked and deemed to be operating normally. I'd be interested in
reviewing problems with the Glucometer machine. Thank you for all your
help.
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Request for Question Clarification by
pafalafa-ga
on
02 Mar 2004 07:40 PST
>>I'd be interested in reviewing problems with the Glucometer machine.<<
Would you like me to post the details about how to access the list of
problems as an answer to your question?
I just want to make sure this is an acceptable answer for you since --
as I said earlier -- I have not seen any mention of specific problems
with the system memory.
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