BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 1930860 · Received December 16, 2010

    Report

    Report Number
    1823260-2010-07534
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 14, 2010
    Report Date
    January 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED MOBILE BLOOD GLUCOSE RESULTS: 6.41 A.M. HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 33.3 MMOL/L 6.45 A.M. HI 6.47 A.M. 10.8 MMOL/L 6.50 A.M. 18.4 MMOL/L 6.52 A.M. 11.8 MMOL/L 6.54 A.M. 4.3 MMOL/L 6.56 A.M. 30.9 MMOL/L REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. 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 277068

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR