BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK COMPACT PLUS

    MDR report key: 1771264 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01582
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    December 24, 2007
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A BLOOD GLUCOSE TEST RESULT OF 5 MG/DL WHICH IS OUTSIDE THE NUMERIC READING RANGE OF 10-600 MG/DL OF THE COMPACT PLUS SYSTEM. REPORTER STATED SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THAT TIME. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT. REPORTER STATED THAT SHE LOST THE METER AND IT IS POSSIBLE NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR LYRICA - ABOUT 1.5 YEARS - 300MG TAB TWICE DAILY| PRINZIDE - ABOUT 1 YEAR - 20/12.5MG TAB ONCE DAILY| FERROUS SULFATE - 1 MONTH - 325MG TAB TWICE DAILY| LASIX - COUPLE YEARS - 40MG TAB ONCE DAILY| EQUETRO - ABOUT 1.5 YRS - 200MG 2 TABS TWICE DAILY| ABILIFY - ABOUT 6 MONTHS - 15MG TAB ONCE DAILY| METFORMIN - ABOUT 2 YEARS - SLIDING SCALE| LEVOXYL - ABOUT 10 YEARS - 175MG TAB ONCE DAILY| NEXIUM - ABOUT 2 YEARS - 40MG TAB ONCE DAILY