BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2922754 · Received January 18, 2013

    Report

    Report Number
    1823260-2013-00343
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    November 21, 2012
    Report Date
    February 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULTS OF 50 MG/DL AND 80 MG/DL WITHIN 10 MINUTES. HE SELF-TREATED SYMPTOMS OF HYPOGLYCEMIA BY DRINKING DRINKING JUICE, THEN TESTED BLOOD GLUCOSE AS 50 MG/DL WITH COMPACT PLUS SYSTEM. SAME SYSTEM RETEST RESULT 10-15 MINUTES LATER WAS 81 MG/DL. NO ADVERSE EVENT WAS REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27567 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG TWICE A DAY| GLUCOPHAGE TWICE A DAY