BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ADVANTAGE TEST STRIPS

    MDR report key: 3241283 · Received July 22, 2013

    Report

    Report Number
    1823260-2013-04411
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 21, 2013
    Report Date
    September 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT ARRIVED IN THE EMERGENCY ROOM VIA AMBULANCE AND RECEIVED THE FOLLOWING RESULTS ON THE INFORM SYSTEM COMPARED TO LAB RESULTS WITHIN 5 MINUTES: 7.0 MMOL/L (INFORM METER) AND 1.4 MMOL/L (LAB). THE PATIENT "DID NOT CLINICALLY LOOK LIKE HE HAD A BLOOD SUGAR OF 7.0 MMOL/L." THE PATIENT WAS "TREATED FOR HYPOGLYCEMIA." NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE PATIENT HAS SINCE BEEN DISCHARGED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340252 ACCU-CHEK ® ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551928

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR