BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1885540 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06446
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 28, 2010
    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

    STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS BLOOD GLUCOSE RESULTS: 0857, 187 MG/DL, CUSTOMER TOOK 10 UNITS OF NOVOLOG 0905, 33 MG/DL 0908, 61 MG/DL 0909, 35 MG/DL. CUSTOMER HAD BLURRY VISION AND FELT NERVOUS WITH 187 MG/DL RESULT, FELT THE SAME WAY WITH 33 MG/DL AND 35 MG/DL. STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR NOVOLOG| LANTUS