BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3921481 · Received July 9, 2014

    Report

    Report Number
    1823260-2014-04998
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 10, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 78 MG/DL ON HIS AVIVA SYSTEM, 137 MG/DL ON ADVANTAGE SYSTEM WITHIN 10 MINUTES USING SAME FINGERSTICK. NO ADVERSE EVENT WAS REPORTED. 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
    402035 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551997

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR ASPIRIN| HUMULIN N| HUMULIN R| CRESTOR| ATENOLOL| METFORMIN| PREVACID| LEVOTHYROXINE| LOSARTAN HCTZ| ISOSORBIDE