BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 4221029 · Received November 3, 2014

    Report

    Report Number
    1823260-2014-08457
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    December 16, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 284 MG/DL (ADVANTAGE)(SYSTEM 1) AND 155 MG/DL AND 161 MG/DL (AVIVA)(SYSTEM 2). NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702819 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 552081

    Patients

    Seq Age Sex Outcome Treatment
    1 094 YR GLIMEPIRIDE| LOSARTAN| ATENOLOL| HYDROCHLOROTHIAZIDE| VESICARE| CANE| WALKER| FENOFIBRATE| JANUVIA