BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1812940 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05031
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SERVICE REPORT THAT THERE WAS A BROKEN PLASTIC SIDE PIECE. NO ADVERSE CONSEQUENCES WERE ALLEGED.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT HE OBTAINED A RESULT OF 113 MG/DL ON THE ADVANTAGE SYSTEM WITH EXPIRED STRIPS AND FELT CONFUSED BEFORE PASSING OUT 15 MINUTES LATER. THE CUSTOMER REPORTED THAT HIS FRIENDS CALLED AN EMERGENCY UNIT, THEY ARRIVED 15 MINUTES LATER, OBTAINED A RESULT OF 25 MG/DL ON THEIR SYSTEM AND TREATED THE CUSTOMER WITH MEDICATION. REPORTER STATED THAT HE WAS TAKEN TO THE HOSPITAL AND GIVEN ORANGE JUICE AND FOOD THERE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE LFR ROCHE DIAGNOSTICS NA 550788

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR Required Intervention CELEXA| LANTUS| SIMVASTATIN| NOVOLOG| DEPAKOTE