BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2082910 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02481
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    May 3, 2011
    Report Date
    November 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). MEDWATCH WITH IDENTIFIER (B)(6) IS FOR COMPACT PLUS SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR AVIVA NANO SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED SYMPTOMS OF HYPOGLYCEMIA, BLOOD GLUCOSE RESULTS OF 9.2 MMOL/L ON AVIVA NANO SYSTEM, 3.1 MMOL/L ON COMPACT PLUS SYSTEM WITHIN 10 MINUTES. CUSTOMER SELF-TREATED WITH FOOD, RETEST RESULT 15 MINUTES LATER WITH THE COMPACT PLUS SYSTEM WAS 4.2 MMOL/L. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    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 207238P

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR HUMALOG| LANTUS 32 UNITS 1XDAY