BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 1880096 · Received October 22, 2010

    Report

    Report Number
    1823260-2010-06323
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 22, 2010
    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)(6). STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS (B)(6) 2010 AT 10:10 PM 83 MG/DL AND 10:13 PM 214 MG/DL ON THE MOBILE SYSTEM. REPORTED A SECOND, SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS (B)(6) 2010 AT 8:10 AM 104 MG/DL AND 8:14 PM 295 MG/DL ON THE SAME SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. STRIPS NOT AVAILABLE FOR RETURN, 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR