BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1910916 · Received November 30, 2010

    Report

    Report Number
    1823260-2010-07062
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    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).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SUDDEN PERFORMANCE DECREMENT AND PAIN RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6), 2010, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 33 MG/DL AND 86 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 20727241

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR "BERLIN INSULIN H"| LIPROLOG