BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM TEST, BLOOD GLUCOSE, OVER THE COUNTER

    MDR report key: 17530525 · Received August 12, 2023

    Report

    Report Number
    MW5137444
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    April 6, 2009
    Manufacturer
    UNKNOWN
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE ENCLOSED DOCUMENT IS OUR MONTHLY REPORT FOR COMPLAINTS RECEIVED BY LIFESCAN, INC., REGARDING COUNTERFEIT LIFESCAN DEVICE(S) (GLUCOSE TEST STRIPS) FOR THE MONTH OF (B)(6) 2009. MALFUNCTIONS - NOT ENOUGH BLOOD, UNIT POWERS OFF DURING USE, COUNTERFEIT LABELING THE SPREADSHEET LISTS COMPLAINTS BY STRIP LOT NUMBER AND CONTAINS LINE-ITEM LISTINGS FOR EACH COMPLAINT BY SERVICE REQUEST (SR)#, ALERT DATE, PRODUCT NAME, LOT#, ADVERSE EVENT OR MAL FUNCTION (BRIEF DESCRIPTION INCLUDED), AND COUNTRY WHERE THE COMPLAINT ORIGINATED (USA OR NON-USA). (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940157 SYSTEM TEST, BLOOD GLUCOSE, OVER THE COUNTER SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW UNKNOWN 260340 X3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown