BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2133231 · Received June 20, 2011

    Report

    Report Number
    1823260-2011-03325
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 3, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH A1 IDENTIFIER (B)(6) IS FOR COMPACT PLUS SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR COMPACT PLUS SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 119 MG/DL ON COMPACT PLUS SYSTEM 1, 72 MG/DL ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. 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
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20729745

    Patients

    Seq Age Sex Outcome Treatment
    1 086 YR SYMLIN 3XDAY| "TIZMEPLINE" 1XDAY| HUMALOG| LANTUS 2XDAY