BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1980814 · Received February 7, 2011

    Report

    Report Number
    1823260-2011-00670
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    February 2, 2011
    Report Date
    July 27, 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

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 13.2 MMOL/L AND 6.2 MMOL/L; 10.7 MMOL/L AND 5.6 MMOL/L THE COMPARISONS WERE PERFORMED ON DIFFERENT DATES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS 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 20727742

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR CALCIUM MAGNESIUM 2/DAY| ZOPICLONE AT BEDTIME| B12 ONCE A DAY| ASA ONCE A DAY| SYNTHROID ONCE A DAY| METFORMIN 3 TIMES A DAY| VITAMIN D ONCE A DAY