BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3022307 · Received March 27, 2013

    Report

    Report Number
    3008382007-2013-06295
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER AND TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: METER- 3/18/2013, TEST STRIPS- 3/27/2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THE SUBJECT METER READ INACCURATELY HIGH. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "275 MG/DL" WITH THE SUBJECT METER AT 12:48AM AND "232 MG/DL" AT 1:45AM. THE PATIENT ALSO REPORTED OBTAINING A BLOOD GLUCOSE READING OF "56 MG/DL" ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF ONE OF THE READINGS NOTED PREVIOUSLY. ON A DIFFERENT OCCASION, THE REPORTER ALSO CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "275 AND 232 MG/DL" WITH THE SUBJECT METER AND "84 MG/DL" ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30% AND/OR 30 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125484 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3414113

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR