BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2232152 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03109
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT THE FIELD SERVICE ENGINEER (FSE) PERFORMED REAGENT PIPETTOR ALIGNMENTS AND SUBSEQUENTLY VERIFIED INSTRUMENT PERFORMANCE VIA A HIGH SENSITIVITY SYSTEM CHECK WHICH GENERATED ACCEPTABLE RESULTS. THE INSTRUMENT WAS RETURNED INTO SERVICE UPON THE COMPLETION OF VERIFIED REPAIRS. NO DEFINITIVE ROOT CAUSE WAS DETERMINED FOR THIS EVENT TO DATE.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INCORRECTLY POSSESSED A RESULTS HEADER REFERENCING "ACCUTNI". THE CORRECT RESULTS HEADER SHOULD HAVE REFERENCED PROGESTERONE. ALSO THE ORIGINAL REPORT REFERENCED A RESULT UNIT OF NG/ML. THE CORRECT UNITS FOR THIS EVENT'S PROGESTERONE RESULTS IS NMOL/L.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMPRECISE PROGESTERONE RESULTS WERE GENERATED FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE ON (B)(6) 2011. THE INITIAL PROGESTERONE RESULT WAS HIGHER THAN EXPECTED. UPON REPEAT ON THE SAME INSTRUMENT, THE PATIENT SAMPLE RECOVERED A LOWER PROGESTERONE RESULT. THE SAMPLE WAS ALSO TESTED ON AN ALTERNATIVE INSTRUMENT WHICH GENERATED LOWER RESULTS IN ALIGNMENT WITH THE REPEAT RESULT. COLLECTIVELY, THE RESULTS WERE OUTSIDE THE ASSAY'S PRECISION CLAIMS. THE IMPRECISE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY HENCE THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE AND SPUN PRIOR TO TESTING. THE SAMPLE WAS A FULL DRAW AND THE PLASMA DID NOT LOOK HEMOLYZED OR TURBID. AN INSTRUMENT SYSTEM CHECK GENERATED RESULTS WHICH MET ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT. THE INSTRUMENT'S PROGESTERONE QUALITY CONTROL RESULTS WERE WITHIN ONE STANDARD DEVIATION OF MEAN DURING THE TIMEFRAME OF THIS EVENT. THERE WERE NO ISSUES POSTED TO THE INSTRUMENT'S EVENT LOG AND THE PROGESTERONE RESULTS WERE THE ONLY RESULTS OR ASSAY IN QUESTION TO DATE PATIENT SPECIFIC INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS PROGESTERONE REAGENT