BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2832896 · Received November 14, 2012

    Report

    Report Number
    1823260-2012-05765
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 8, 2012
    Report Date
    March 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 STATES PATIENT TESTED 135 MG/DL AT 06:30 WHILE USING THE ADVANTAGE SYSTEM WITH COMFORT CURVE TEST STRIPS. THE PATIENT WAS FOUND PASSED OUT AT 07:00; PATIENT WAS TREATED WITH A GLASS OF JUICE, AND WITHIN 15 MINUTES PARAMEDICS ARRIVED. PATIENT TESTED 71 MG/DL "AROUND" 07:15 ON THE PROFESSIONAL METER. SHE WAS TREATED WITH A GLUCOSE IV AND ADMITTED TO THE HOSPITAL FOR 3 DAYS. PATIENT'S CONDITION HAS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE 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 ROCHE DIAGNOSTICS NA 551690

    Patients

    Seq Age Sex Outcome Treatment
    1 085 YR Hospitalization| R ACTOS| HYDRALAZINE| ATENOLOL| LISINOPRIL