BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ADVANTAGE PLUS TEST STRIPS

    MDR report key: 1792018 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04748
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 31, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTS BEING UNCONSCIOUS WITH RESULT OF 11.5 MMOL/L OBTAINED ON THE ADVANTAGE PLUS SYSTEM. 10-15 MINUTES LATER CUSTOMER TESTED 2.4 MMOL/L ON PROFESSIONAL DEVICE. SHE WAS TREATED WITH GLUCOSE AND ADMITTED TO THE HOSPITAL FOR 6 DAYS. REQUESTED RETURN OF SUSPECT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® ADVANTAGE PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 451098

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R