BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2920337 · Received January 17, 2013

    Report

    Report Number
    1823260-2013-00322
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 30, 2012
    Report Date
    February 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 138 MG/DL ON ACTIVE SYSTEM, 76 MG/DL ON COMPACT PLUS SYSTEM WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26230 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20734043

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR