BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACCUTREND TEST STRIPS

    MDR report key: 2558932 · Received May 3, 2012

    Report

    Report Number
    1823260-2012-02401
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    April 24, 2012
    Report Date
    May 3, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(4). MEDWATCH WITH IDENTIFIER (B)(6) IS FOR PERFORMA SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR ACCUTREND GCT SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 223 MG/DL ON CUSTOMER'S PERFORMA SYSTEM, 103 MG/DL ON PHARMACY'S ACCUTREND GCT SYSTEM WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® ACCUTREND TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20317702

    Patients

    Seq Age Sex Outcome Treatment
    1