BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1222403 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08169
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER WAS DISORIENTED AND NOT ACTING LIKE HERSELF; PERFORMED BLOOD GLUCOSE TEST WITH A RESULT OF 425 MG/DL ON THE CUSTOMER WHILE USING THE ADVANTAGE SYSTEM. REPORTER STATED THAT SHE CALLED THE EMTS, THEY ARRIVED 15 MINUTES LATER, OBTAINED A RESULT OF 20 MG/DL ON THEIR SYSTEM, AND TREATED HER WITH A GLUCOSE IV. REPORTER STATED THE CUSTOMER WAS THEN GIVEN AN EGG SANDWICH THAT SHE COULD CONSUME ON HER OWN. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT REC'D. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT. REPORTER STATED THAT STRIPS HAVE BEEN DISCARDED AND SO NO PRODUCT WILL BE RETURNED FOR EVAL.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention LANTUS - 5-6 YEARS| GLUCOTROL - 5-6 YEARS