BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2040169 · Received April 5, 2011

    Report

    Report Number
    1823260-2011-01889
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 26, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR ADVANTAGE SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR ADVANTAGE SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 355 MG/DL, ON ADVANTAGE SYSTEM 1, 84 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. SUCCESSFULLY TREATED SYMPTOMS OF HYPOGLYCEMIA. REPORTED A SECOND, SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS OF 342 MG/DL ON ADVANTAGE SYSTEM 1, 102 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. SUCCESSFULLY TREATED SYMPTOMS OF HYPOGLYCEMIA. 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 ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551277

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR GLYBURIDE 2XDAY| OMEPRAZOLE 2XDAY| HYDROCHLOROTHIAZIDE 1XDAY| ASPIRIN 1XDAY| LISINOPRIL 1XDAY| METFORMIN 2XDAY| SIMVASTATIN 1XDAY| SLEEP APNEA MACHINE