BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 2063380 · Received April 19, 2011

    Report

    Report Number
    1823260-2011-02111
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 3, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6) MEDWATCH WITH IDENTIFIER (B)(6) IS FOR CUSTOMER'S RESULTS WITH MOBILE SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS CUSTOMER'S RESULTS WITH AVIVA NANO SYSTEM. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR CUSTOMER'S FATHER'S RESULTS WITH MOBILE SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS CUSTOMER'S FATHER'S RESULTS WITH AVIVA NANO SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED CUSTOMER'S BLOOD GLUCOSE RESULTS OF 15.8 MMOL/L ON MOBILE SYSTEM, 5.9 MMOL/L ON AVIVA NANO SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. 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 MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278008

    Patients

    Seq Age Sex Outcome Treatment
    1 011 YR INSULIN