BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1955406 · Received January 10, 2011

    Report

    Report Number
    1823260-2011-00171
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 70 MG/DL ON CUSTOMER'S AVIVA SYSTEM, 130 MG/DL ON ADVANTAGE SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. 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 ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE LFR ROCHE DIAGNOSTICS NA 551114

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR LISINOPRIL| NOVOLOG 70/30| BLOOD PRESSURE MONITOR| LANTUS