BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1071754 · Received July 8, 2008

    Report

    Report Number
    2122870-2008-00214
    Event Type
    Other
    Date Received
    July 8, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THEY HAD ONE QC FAILURE IN 2008, AND QC PASSED UPON REPEAT. BASED ON ARCHIVED DATA, SEVERAL QC FAILURES WERE NOTED THE NEXT DAY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED PERI-PUMP TUBING THAT LOOKED WORN WHICH WAS REPLACED. THE FSE FOUND PROBLEMS WITH SEVERAL TRANSDUCERS WHICH WERE REPLACED. PER FSE, ALL REAGENT PRECISION VALVES AND PUMPS WERE REWORKED TO ADDRESS QC IMPRECISION AND THEN HARDWARE VERIFICATION PROTOCOL WAS PERFORMED, AND RESULTS PASSED WITHIN SPECIFICATIONS. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT, ALL ACCU TNI RESULTS WERE WITHIN THE RISK STRATIFICATION RANGE, AND BELOW THE AMI CUT-OFF OF 0.50 NG/ML. DUE TO THE POTENTIAL FOR THIS EVENT TO RECUR UNKNOWINGLY, THERE IS A POTENTIAL THAT A PIVOTAL ASSAY COULD BE ERRONEOUSLY REPORTED AND TREATMENT DECISION MAY BE AFFECTED. HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A BECKMAN COULTER INC. (BCI) THAT THE ER PHYSICIAN QUESTIONED ACCU TNI RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. TWO SAMPLES WERE TESTED FOR ACCU TNI AND RESULTS WERE 0.396NG/ML AND 0.137NG/ML. THE RESULTS WERE WITHIN THE RISK STRATIFICATION RANGE; HOWEVER, THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. BOTH SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND LOWER RESULTS WERE OBTAINED ("APPROX 0.04NG/ML AND APPROX 0.02NG/ML"). CORRECTED REPORTS WERE SENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA