BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1905053 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06926
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 10, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULTS OF 170 MG/DL AND 93 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, 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 207249

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR