BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1000378 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01585
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF 120MG/DL WHILE EXHIBITING HYPOGLYCEMIC SYMPTOMS. WITHIN 30-45 MINUTES, THE CUSTOMER WAS UNRESPONSIVE AND THE PARAMEDICS WERE CALLED. THE CUSTOMER TESTED 34MG/DL ON THE PARAMEDIC'S DEVICE AND RECEIVED A GLUCOSE IV. SHE WAS TRANSPORTED TO THE HOSPITAL, HOWEVER, NO FURTHER TREATMENT FOR DIABETES WAS RECEIVED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549830

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention APIDRA - 6 MONTHS| HYDROCHLOROTHIAZIDE - 6-8 MONTHS| VYTORIN - 6-8 MONTHS| ALPRAZOLAM - 6-8 MONTHS| LANTUS - 6 MONTHS| ENALAPRIL - 6-8 MONTHS| ASPIRIN - 6-8 MONTHS| CIPROFLOXACIN - 100MG/DAY| CLONIDINE - 6-8 MONTHS| FISH OIL SUPPLEMENT - 6 MONTHS