BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5821-03, CHEMISTRY ANALYZER

    MDR report key: 2884267 · Received December 22, 2012

    Report

    Report Number
    2050012-2012-01957
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K112412
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL ERRONEOUS RESULTS WERE REQUESTED BY BEC SEVERAL TIMES; HOWEVER, NO VALUES FOR THE REPORTED ERRONEOUS RESULTS WERE COMMUNICATED BACK TO BEC. UPON ADDITIONAL COMMUNICATION WITH THE HOSPITAL LAB TECHNICIAN, BECKMAN COULTER WAS INFORMED THAT NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED SINCE CONFIRMATION WAS RECEIVED FROM THE CUSTOMER THAT NO ERRONEOUS PATIENT RESULTS WERE GENERATED. BASED ON THAT ASSESSMENT, BECKMAN COULTER IS CLOSING THE INVESTIGATION ON THIS EVENT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DURING A BEC FIELD SERVICE ENGINEER'S VISIT, HAIRLINE CRACKS WERE OBSERVED ON THE THREE ELECTRODES INSTALLED ON THE ANALYZER. REPLACEMENT STOCK WAS ORDERED BUT THESE ALSO HAD THE SAME CRACKS ON THEIR CASING. THE ERRONEOUS SODIUM RESULTS APPEARED TO HAVE BEEN SO LOW AS SO BE INHERENTLY UNBELIEVABLE. IT IS NOT LIKELY, THEREFORE, THAT THE ERRONEOUS RESULTS WOULD BE REPORTED BY THE LABORATORY OR SUBSEQUENTLY ACTED UPON BY THE PHYSICIAN. FURTHERMORE, THE DEFECT ALSO CAUSES DIFFICULTIES IN CALIBRATION OF THE INSTRUMENT, THEREBY MAKING THE PROBLEM READILY APPARENT TO THE LABORATORY USER. THEREFORE, THE MEDICAL RISK ASSOCIATED WITH THE HAIRLINE CRACKS IS SIGNIFICANTLY MITIGATED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THEY HAD OBSERVED DIFFICULTIES WITH ELECTROLYTE CALIBRATION. PER CUSTOMER, LOW SODIUM (NA) RESULTS WERE GENERATED. THE LABORATORY RECOGNIZED THAT THE RESULTS WERE LOW AND THESE SAMPLES WERE THEN RETESTED ON A SECOND ANALYZER GENERATING ACCEPTABLE RESULTS. THE ACCEPTABLE RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO AFFECT TO PATIENTS WITH REGARD TO THIS EVENT. THE ACTUAL ERRONEOUS RESULTS WERE REQUESTED BY BEC SEVERAL TIMES HOWEVER TO DATE, NO VALUES FOR THE REPORTED ERRONEOUS RESULTS HAVE BEEN COMMUNICATED BACK TO BEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU5821-03, CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JGS BECKMAN COULTER INC. AU 5821-03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1