BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT STRIPS

    MDR report key: 2180176 · Received July 27, 2011

    Report

    Report Number
    1823260-2011-04031
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULT OF 0.7 MMOL/L AND 5.8 MMOL/L WITHIN 10 MINUTES. 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 STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 208008

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR BYETTA| UNSPECIFIED ASTHMA MEDS| UNSPECIFIED ARTHRITIS MEDS| METFORMIN| UNSPECIFIED BYPASS SURGERY MEDS| UNSPECIFIED INSULIN 1XDAY