BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING ENHANCED METER

    MDR report key: 2800560 · Received October 22, 2012

    Report

    Report Number
    2939301-2012-12249
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    October 9, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (SUBMISSION 12/12/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE METER WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(4) 2012. THE RETURNED METER PASSED TESTING. THE ALLEGED COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT CONTACTED LIFESCAN ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC COMPARED TO THE SAME METER. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "1.1 MMOL/L" AND "7.6 MMOL/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3326370

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR