BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 1885061 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06393
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE SURGEON INDICATED THAT THE NECK OF THE HIP POSITIONER INSTRUMENT WAS CRACKED AND NEEDED TO BE REPLACED.

    Description of Event or Problem · 1

    CALLER REPORTED MOBILE SYSTEM BLOOD GLUCOSE RESULTS OF 354 MG/DL AND 103 MG/DL WITHIN 1 MINUTE. 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 277030

    Patients

    Seq Age Sex Outcome Treatment
    1 009 YR INSULIN| EUTIROC 50