BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1780634 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08431
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    August 29, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT PT OBTAINED A BLOOD GLUCOSE RESULT OF 135 MG/DL ON THE COMPACT SYSTEM. AN UNSPECIFIED TIME LATER, PT'S BLOOD GLUCOSE WAS REPORTEDLY RETESTED ON A PHYSICIAN'S DEVICE WITH A RESULT OF 35 MG/DL. REPORTER INDICATED THAT PT EXPERIENCED HYPOGLYCEMIA. REPORTER DID NOT INDICATE IF PT REQUIRED OR RECEIVED ANY TREATMENT FOR HYPOGLYCEMIA. THE MFR REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVAL.

    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 206612

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK