BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3142678 · Received June 3, 2013

    Report

    Report Number
    1823260-2013-03311
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 10, 2013
    Report Date
    July 23, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 COMPACT PLUS SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS COMPACT PLUS SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 475 MG/DL, 275 MG/DL, AND 220 MG/DL ON COMPACT PLUS SYSTEM 1, 108 MG/DL ON COMPACT PLUS SYSTEM 2 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
    244046 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR HUMULIN 70/30| PACEMAKER