BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU680 CHEMISTRY ANALYZER WITH ISE

    MDR report key: 2912193 · Received January 11, 2013

    Report

    Report Number
    9612296-2013-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE ORIGINAL TP CALIBRATION AND QC WERE ALL FOUND TO BE ACCEPTABLE BEFORE THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE DISCOVERED THE TP PRECISION ISSUES. THE FSE REPLACED THE R2 SYRINGE AND PROBE AND THEN RAN WATER BLANK TEST WHICH PASSED. THE TP ASSAY WAS RECALIBRATED AND QC WAS PERFORMED; ALL RESULTS PASSED. TO DATE, THERE HAVE BEEN NO FURTHER TP ISSUES REPORTED FROM THIS CUSTOMER SITE. R2 REAGENT PROBE AND SYRINGE REPLACEMENT FIXED THE PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED OBTAINING LOW TOTAL PROTEIN (TP) RESULTS FOR PATIENT SAMPLES WHICH WERE GENERATED FROM AN AU680 CHEMISTRY ANALYZER. THE CUSTOMER STATED THAT THEY WERE QUESTIONED BY SEVERAL DOCTORS ABOUT TP RESULTS THAT WERE LOWER THAN EXPECTED. CUSTOMER NOTED THAT THE LOW TP RESULTS WERE SHOWING UP AFTER HAVING PROCESSED ABOUT 150 PATIENT SAMPLES. THE CUSTOMER PROVIDED ONLY THE FOLLOWING EXAMPLES OF PATIENT RESULTS: 5.9, 5.7, 5.4 WITH A RERUN OF 6.0, 6.7 6.5 RESPECTIVELY. THE CUSTOMER DID NOT PROVIDE ANY PATIENT RESULTS DOCUMENTATION FOR THIS INVESTIGATION. THE CUSTOMER DID NOT INDICATE THE NUMBER OF PATIENT RESULTS THAT WERE ERRONEOUS. ONCE THE LOW TP RESULTS WERE DISCOVERED, ALL SAMPLES WERE REPEATED BACK TO THE PREVIOUS QC RUN. REPEATED RESULTS WERE PERFORMED ON THEIR OTHER INSTRUMENT. CUSTOMER STATED THAT SOME AMENDED REPORTS HAD BEEN ISSUED. PATIENT RESULTS WERE RELEASED OUT OF THE LAB. ALTHOUGH THE CUSTOMER DID NOT RECEIVE REPORTS OF CHANGE TO PATIENT TREATMENT, IT IS UNKNOWN IF ANY PATIENT WAS AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18038 AU680 CHEMISTRY ANALYZER WITH ISE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. AU681-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1