BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® ACTIVE TEST STRIPS

    MDR report key: 2183244 · Received July 28, 2011

    Report

    Report Number
    1823260-2011-04069
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE ACTIVE SUSPECT DEVICE SYSTEM USED. REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE PERFORMA SUSPECT DEVICE SYSTEM USED.

    Description of Event or Problem · 1

    REPORTER ALLEGED RECEIVING THE RESULTS OF 183 MG/DL AND 89 MG/DL ON THE PERFORMA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 78 MG/DL ON THE ACTIVE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 23433333

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR