BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1830117 · Received September 10, 2010

    Report

    Report Number
    1823260-2010-05365
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 24, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 18 MMOL/L AND 6.3 MMOL/L WITHIN 10 MINUTES, "(SAME METER SAME TIME)", ON THE ACCU-CHEK COMPACT PLUS SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER, STRIPS, AND CONTROLS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    OVERSENSING WAS REPORTED ON THE ATRIAL LEAD DURING A SENSING TEST. THE CLINICIAN AND DOCTOR REPORT THAT THE PATIENT WAS IN SINUS RHYTHM AT TIME OF SENSING TEST AND THE NOISE WAS REPRODUCIBLE DURING PROVOCATIVE TESTING. IMPEDANCE IN THE ATRIUM IS 440 OHMS AND STEADY SINCE IMPLANT. ON (B)(6) 2010- THE DOCTOR DECIDED TO PROGRAM THE DEVICE TO SINGLE CHAMBER AND SO NO SURGICAL INTERVENTION IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 20723841

    Patients

    Seq Age Sex Outcome Treatment
    1