BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM

    MDR report key: 2250792 · Received September 6, 2011

    Report

    Report Number
    2250792
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    February 27, 2009
    Report Date
    March 24, 2009
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS FOUND UNRESPONSIVE. BLOOD SUGAR LEVEL TESTED WITH THIS EQUIPMENT PRODUCED RESULTS OF 103. LAB PERSONNEL CAME TO DRAW BLOOD FOR SERUM BLOOD SUGAR TEST WITHIN FIVE MINUTES AND THE RESULT WAS 23.======================MANUFACTURER RESPONSE FOR BLOOD GLUCOSE METER, N/A (PER SITE REPORTER)======================IT HAS BEEN DETERMINED THE DEVICE WAS WORKING PROPERLY THROUGH AN INTERNAL TECHNICAL EVALUATION. THE OBSERVED PROBLEM WAS RELATED TO IMPROPER HANDLING OF REAGENT STRIP. MANUFACTURER'S REPRESENTATIVE CONFIRMED THE LIKELIHOOD THAT THE DISCREPANCY WAS RELATED TO STORAGE OF REAGENT STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFORM BLOOD GLUCOSE METER NBW ROCHE DIAGNOSTICS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR