BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2895044 · Received January 3, 2013

    Report

    Report Number
    1823260-2013-00053
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 30, 2012
    Report Date
    February 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH (B)(6) IS FOR COMPACT PLUS SYSTEM 1, MEDWATCH WITH (B)(6) IS FOR COMPACT PLUS SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 300 MG/DL ON COMPACT PLUS SYSTEM 1, COMPACT PLUS SYSTEM 2 RESULT OF 109 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2957 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20733944

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR METFORMIN| IBUPROFEN