BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2840541 · Received November 20, 2012

    Report

    Report Number
    1823260-2012-05895
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 29, 2012
    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
    TX, 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. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED. (B)(4): STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED AN INCIDENT IN WHICH FATHER'S ADVANTAGE SYSTEM GAVE A BLOOD GLUCOSE RESULT OF 180 MG/DL AT 5:15 PM. AT 6:00 PM, THE CALLER NOTED HIS FATHER DISPLAY SYMPTOMS OF HYPOGLYCEMIA. PARAMEDICS WERE CALLED, ARRIVED AT 6:20 PM, TESTED CUSTOMER'S BLOOD GLUCOSE AT 31 MG/DL, TREATED HIM WITH AN IV. PARAMEDICS RETESTED AFTER FIVE MINUTES, RESULT WAS 217 MG/DL. CUSTOMER WAS REPORTED TO FEEL FINE SUBSEQUENTLY. STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR Required Intervention LANTUS| NOVOLOG