BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2083438 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02496
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 11, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS TAKING HUMULIN R BASED ON RESULT OF HI (GREATER THEN 600 MG/DL) OBTAINED ON THE AVIVA SYSTEM. CUSTOMER STATES SHE PASSED OUT AND HIT HER HEAD 5 MINUTES LATER; PARAMEDICS WERE CALLED, AND CUSTOMER TESTED 23 MG/DL ON PROFESSIONAL DEVICE 15 MINUTES LATER. CUSTOMER WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS AND TREATED WITH A "SUGAR WATER" IV. CUSTOMER'S CONDITION IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR Hospitalization| R SYNTHROID| "TOPAL EXCEL"| HUMULIN R| HUMULIN 70/30| LISINOPRIL