BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1942347 · Received December 30, 2010

    Report

    Report Number
    1823260-2010-07762
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 24, 2010
    Report Date
    February 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AFFILIATE DOCUMENTED THE RECEIPT OF THE COMPLAINT LOT, 201267, BUT WHEN THE GLOBAL INVESTIGATION UNIT RECEIVED THE RETURNED PRODUCT THEY DOCUMENTED THE LOT NUMBER AS 201287. THEY WERE ASKED AND VERIFIED THE LOT NUMBER AS 201287.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 119 MG/DL (AVIVA) AND 54 MG/DL (COMPACT PLUS) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20726744

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR METFORMIN| LANTUS| GLIPIZIDE