BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 1982412 · Received February 9, 2011

    Report

    Report Number
    1823260-2011-00717
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 28, 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 A1 IDENTIFIER (B)(6) IS FOR MOBILE SYSTEM, MEDWATCH WITH A1 IDENTIFIER (B)(6) IS FOR AVIVA SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED PATIENT BLOOD GLUCOSE RESULTS OF 9.2 MMOL/L ON MOBILE SYSTEM, 2.7 MMOL/L ON AVIVA SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METERS AND STRIPS.

    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 278004

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR SIMVASTATIN| DOXAZOSIN| LANTUS 1XDAY| NOVORAPID| ADALAT 1XDAY| ASPIRIN 1XDAY| "DIOSOLATIN"| "FIBERGELL"| LEVOTHROID| "TAMAZPRAM"| "VALZATAM"