BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 4102239 · Received September 19, 2014

    Report

    Report Number
    2122870-2014-00636
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SPECIALIST (CTS) ADVISED THE CUSTOMER TO RECALIBRATE THE ACCUTNI+3 ASSAY. AFTER MULTIPLE FAILED CALIBRATION ATTEMPTS, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REPLACED THE ASPIRATE PROBES, PERISTALTIC PUMP TUBING, THE SAMPLE PROBE, AND THE TIP ON REAGENT PIPETTOR #3. A SUBSEQUENT ACCUTNI+3 CALIBRATION PASSED WITH AN EXPECTED S0 RLU. A BEC SUBJECT MATTER EXPERT (SME) CONFIRMED THAT ELEVATED S0 RLU MEAN DURING ACCUTNI+3 CALIBRATION IS CONSISTENT WITH MALFUNCTION OF ONE OR MORE OF THE REPLACED PARTS. ASSOCIATED MDRS: 2122870-2014-00633, 2122870-2014-00634, 2122870-2014-00635, 2122870-2014-00637, 2122870-2014-00638, 2122870-2014-00639, 2122870-2014-00640. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM GENERATED 54 INDETERMINATE (IND) FLAGGED TROPONIN I (ACCUTNI+3) FOR 47 PATIENT SAMPLES BETWEEN THE DATES OF (B)(6) 2014. THE CUSTOMER ALLEGED THAT THERE MAY HAVE BEEN A DELAY IN PRODUCTION OF PATIENT RESULTS, BUT CONFIRMED THAT PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT. AN ACCUTNI+3 CALIBRATION WAS SUCCESSFULLY PERFORMED ON (B)(6) 2014 USING REAGENT LOT 337132 AND CALIBRATOR LOT 334821; THE S0 RLU (RELATIVE LIGHT UNIT) MEAN WAS ACCEPTABLE. TWO RECALIBRATIONS WERE ATTEMPTED ON (B)(6) 2014 USING THE SAME REAGENT AND CALIBRATOR LOTS AS WELL AS NEW REAGENT AND CALIBRATOR LOTS. BOTH CALIBRATIONS FAILED DUE TO ELEVATED S0 RLU MEAN. THE INSTRUMENT'S LOW-LEVEL QUALITY CONTROL (QC) RESULTS FOR ACCUTNI+3 REMAINED CONSISTENT UNTIL THE CALIBRATION ON (B)(6) 2014; AFTER THE CALIBRATION, LOW LEVEL QC RESULTS WERE LOWER THAN PREVIOUS RESULTS. SEVERAL SYSTEM CHECKS WERE PERFORMED ON (B)(6) 2014 AND FAILED. THIS MDR REPORTS THE RESULTS GENERATED ON (B)(6) 2014; ON (B)(6) 2014, TEN IND-FLAGGED ACCUTNI+3 RESULTS WERE GENERATED FOR NINE PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584031 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1