BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2832534 · Received November 14, 2012

    Report

    Report Number
    2122870-2012-01892
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL SYSTEM PARAMETERS (INCLUDING QC, CALIBRATION, AND SYSTEM CHECKS) WERE PERFORMING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. AN ARCHIVE DATA FILE WAS SUPPLIED BY THE CUSTOMER FOR REVIEW. COMPLAINT INVESTIGATOR REVIEWED THIS FILE AND NO ABNORMALITIES WERE NOTED. EACH OF THE PATIENT SAMPLES WERE ANALYZED USING THE SAME LOT NUMBER OF TBHCG2 REAGENT; HOWEVER, A DIFFERENT REAGENT PACK WAS USED FOR EACH SAMPLE. QC WAS PERFORMED SEVERAL TIMES FROM EACH REAGENT PACK AND WAS FOUND TO BE PASSING WITHIN THE LABORATORY'S ESTABLISHED RANGES. PER CUSTOMER, THE PATIENT SAMPLES WERE FULL DRAWS COLLECTED INTO LITHIUM HEPARIN PLASMA TUBES, WERE OF GOOD QUALITY, AND WERE PROCESSED AT 3000 RPMS FOR 7 MINUTES ON THE LABORATORY'S AUTOMATION LINE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO VERIFY HARDWARE PERFORMANCE IN RESPONSE TO THIS EVENT. THE FSE RAN A CARRYOVER TEST, A SYSTEM CHECK, A HIGH SENSITIVITY SYSTEM CHECK, TBHCG2 CALIBRATION, AND ALL LEVELS OF TBHCG2 QC; ALL RESULTS WERE WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE FSE VERIFIED INSTRUMENT PERFORMANCE WITHOUT PERFORMING ANY ADJUSTMENTS OR REPAIRS AND NOTED NO HARDWARE PERFORMANCE ISSUES WHICH MAY HAVE CAUSED, OR CONTRIBUTED TO, THIS EVENT. IN CONCLUSION, UPON REVIEW OF ALL SUPPLIED DATA, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE A DEFINITIVE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THEY OBTAINED ERRATIC (IMPRECISE) TOTAL BHCG2 (TBHCG2) RESULTS ABOVE THE NORMAL REFERENCE RANGE, AND OUTSIDE THE PRECISION CLAIMS ((B)(4)) STATED IN THE ASSAY'S INSTRUCTION FOR USE (IFU), FOR A (B)(6) FEMALE PATIENT, USING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER. THESE TBHCG2 RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY; HOWEVER, THE RESULTS WERE QUESTIONED BY THE PATIENT'S PHYSICIAN AND IT IS UNKNOWN IF THERE WAS ANY CHANGE TO, OR IMPACT ON, PATIENT TREATMENT. THE PATIENT WAS REDRAWN THE FOLLOWING DAY AND ANALYZED ON THIS DXI 800 ANALYZER. ERRATIC (IMPRECISE) TBHCG2 RESULTS ABOVE THE NORMAL REFERENCE RANGE, AND OUTSIDE THE PRECISION CLAIMS ((B)(4)) STATED IN THE ASSAY'S IFU, WERE AGAIN OBTAINED. THE PATIENT'S INITIAL SAMPLE (FROM (B)(6) 2012) WAS THEN ANALYZED IN DUPLICATE ON THE LABORATORY'S ACCESS 2 INSTRUMENT, AND REPRODUCIBLE TBHCG2 RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED. THESE RESULTS OCCURRED ON ONE PATIENT USING TWO SEPARATE SAMPLES ON TWO DRAW DATES. THIS MDR REPORT IS ADDRESSING THE RESULTS OCCURRED ON (B)(6) 2012 AND AN MDR REPORT 2122870-2012-01891 IS COVERING THE RESULTS OCCURRED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR