BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2904212 · Received January 9, 2013

    Report

    Report Number
    1823260-2013-00186
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 15, 2012
    Report Date
    February 12, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 1. 363 MG/DL AND 111 MG/DL (WITHIN 4 MINUTES) 2. 545 MG/DL AND 94 MG/DL (WITHIN 3 MINUTES) SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES ON SAME DAY. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12712 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20733343

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR AMARYL| GLUCOPHAGE