BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 2070618 · Received April 27, 2011

    Report

    Report Number
    1823260-2011-02275
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 25, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 ACTIVE SYSTEM BLOOD GLUCOSE RESULT OF 3.8 MMOL/L, PROFESSIONAL SYSTEM RESULT 1.8 MMOL/L WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT DUE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 23427933

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR DIABEX| "TRYTRACE"| ACTOS| NOVORAPID 3XDAY| "BETTALOCK"| MICARDIS| "TOBEX"