BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2703-03E CLINICAL CHEMISTRY ANALYZER.

    MDR report key: 2221140 · Received August 23, 2011

    Report

    Report Number
    2050012-2011-04801
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K003721
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS SERUM. PER THE CUSTOMER COMPLAINT RECORD, THE INSTRUMENT SAMPLE ARM HAS BEEN REPLACED DUE TO MISALIGNMENT. INVESTIGATION IS STILL PENDING. ADDITIONAL INFORMATION FOR THIS INVESTIGATION IS BEING REPORTED IN MDR 2050012-2011-04810.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT A PAEDIATRIC GLUCOSE SERUM SAMPLE, FROM AN INFANT PATIENT, GENERATED AN ERRONEOUSLY HIGH RESULT OF 4.46 MMOL/L ON THE (B)(4) CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS IMMEDIATELY QUERIED BY THE CONSULTANT AS THIS INFANT PATIENT WAS HYPOGLYCEMIC, AND ADDITIONAL ON-GOING MONITORING OF THE INFANT HAD SHOWN THE INFANT TO HAVE LOW GLUCOSE. NO TREATMENT WAS ADMINISTERED BASED ON THE ORIGINAL RESULT. ON REQUEST BY THE HOSPITAL CONSULTANT, THE SAME SERUM SAMPLE WAS RE-TESTED AND CONSISTENT RESULTS OF 1.71MMOL/L AND 1.79 MMOL/L WERE OBTAINED. THE SAME PRIMARY TUBE WAS USED FOR ALL TESTS. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2703-03E CLINICAL CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU2701-03ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1