BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 829710 · Received October 19, 2006

    Report

    Report Number
    1823260-2006-06018
    Event Type
    Malfunction
    Date Received
    October 19, 2006
    Date of Event
    October 1, 2006
    Report Date
    October 2, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STRIPS THAT PRODUCED RESULT OF 218MG/DL: 549115, EXPIRE 9/30/07, CAT# 2030365.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF 173MG/DL WHILE THE HOSPITAL'S DEVICE READ 37MG/DL WITHIN 10 MINUTES. WITH A DIFFERENT VIAL OF TEST STRIPS, CUSTOMER OBTAINED A RESULT OF 218MG/DL WHILE THE HOSPITAL DEVICE READ 64MG/DL WITHIN 10 MINUTES. CUSTOMER WAS GIVEN JUICE TO ELEVATE THIS BLOOD GLUCOSE. NO MEDICAL TREATMENT RECEIVED. QUALITY CONTROLS WERE USED ON LOT 549115 AND FELL WITHIN ACCEPTABLE LIMITS. 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 CFR ROCHE DIAGNOSTICS * 548893

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR ACCU-CHEK ADVANTAGE| NOVOLOG| LANTUS