BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1120772 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06233
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TAKING 9 UNITS OF NOVOLOG INSULIN BASED UPON AN AVIVA SYSTEM BLOOD GLUCOSE RESULT OF 221 MG/DL. WHEN SHE RETESTED OVER TEN MINUTES LATER, HER RESULT WAS 100 MG/DL. SHE PASSED OUT, EMT'S WERE CALLED, WHO MEASURED HER BLOOD GLUCOSE AT 31 MG/DL WITH THEIR SYSTEM LESS THAN 10 MINUTES AFTER THE 100 MG/DL RESULT. SHE WAS TREATED AND HOSPITALIZED. THIS CASE WAS REPORTED BASED UPON THE QUALIFYING ELEMENTS OF THE DISCREPANCY AND THE REPORTER'S UNCERTAINTY ABOUT THE TIMELINE OF EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention NOVOLOG SLIDING SCALE - 1 YEAR| NPH INSULIN 68 UNITS/DAY - 1 YEAR