BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1852487 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05875
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    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). 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

    CALLER REPORTED BLOOD GLUCOSE RESULTS AT 8:39 AM, 1.2 MMOL/L AND 8:40 AM 4.0 MMOL/L ON THE COMPACT PLUS SYSTEM. REPORTED A SECOND, SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS AT 12:20 AM, 1.1 MMOL/L AND 12:21 AM 5.0 MMOL/L ON THE SAME SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THEY HAVE ENCOUNTERED AN INCIDENT WITH THE FOLLOWING MEDICAL TUBING. THE LAST BREAKAGE CAUSED A SEVERE CYTOTOXIC SPILL AND CONTAMINATION OF A PT. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    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 207231

    Patients

    Seq Age Sex Outcome Treatment
    1 041 YR INSULIN