BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2173375 · Received July 23, 2011

    Report

    Report Number
    1823260-2011-03914
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    August 29, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTED ADVANTAGE SYSTEM BLOOD GLUCOSE RESULTS OF 80 MG/DL OR 90 MG/DL, PARAMEDIC'S SYSTEM 40 MG/DL WITHIN 10 MINUTES. CUSTOMER HAD SYMPTOMS OF HYPOGLYCEMIA AT THE TIME. PARAMEDICS TREATED WITH TWO TUBES OF GLUCOSE GEL BY MOUTH. SHE FELT BETTER 30 MINUTES LATER AFTER ARRIVING AT HOSPITAL. SHE WAS ADMITTED TO HOSPITAL FOR 2 DAYS. 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 551534

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR NEBULIZER| OXYGEN MACHINE| HUMULIN 70/30 2XDAY