BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2034031 · Received March 30, 2011

    Report

    Report Number
    1823260-2011-01705
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 92 MG/DL ON COMPACT PLUS SYSTEM, 187 MG/DL ON ADVANTAGE SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. COMPACT 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
    1 057 YR METFORMIN| KLOR-CON| LASIX 1XDAY| IBUPROFEN 1XDAY| BREATHING MACHINE