BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2213089 · Received August 16, 2011

    Report

    Report Number
    1823260-2011-04370
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 31, 2011
    Report Date
    September 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 20729944, EXPIRATION DATE (B)(6) 2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 285 MG/DL ON COMPACT PLUS SYSTEM 1 AND RESULT OF 133 MG/DL ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS 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 20729944

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR GLIMEPIRIDE| ACTOS