BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 2941790 · Received February 4, 2013

    Report

    Report Number
    1823260-2013-00630
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 3, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 470578, EXPIRATION DATE 12/31/2013). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 30.9 MMOL/L AND 8.0 MMOL/L WITHIN 10 MINUTES ON THE INFORM SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45805 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 470578

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR ATORVASTIN| DALTEPARIN| "HUMALOG MIX" DAILY| PREDNISOLONE DAILY| ACTRAPID INFUSION| LANSOPRAZOLE| MONTELUKAST| NOVORAPID