BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI

    MDR report key: 3257785 · Received July 31, 2013

    Report

    Report Number
    2122870-2013-00667
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED A SYSTEM CHECK ON THE DAY OF THE EVENT TO EVALUATE INSTRUMENT'S PERFORMANCE AND THE SYSTEM CHECK FAILED. THE CUSTOMER REPLACED THE ASPIRATE PROBES AND RERAN THE SYSTEM CHECK WHICH FAILED AGAIN. A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE CTS ADVISED THE CUSTOMER TO REPLACE THE PERI-PUMP TUBING AND RERUN THE SYSTEM CHECK. THE SYSTEM CHECK FAILED AGAIN AND SERVICE WAS DISPATCHED FOR THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE AND CLEANED THE TRACK ON THE ANALYTICAL MODULE. THE FSE ALSO PULLED AND CLEANED THE WASH WHEEL. THE FSE NOTED THAT THERE WAS NOTHING ON THE WASH WHEEL. THE FSE ALSO PROACTIVELY REPLACED THE WASH ROTOR AND STATOR. THE FSE THEN RAN A PASSING HIGH SENSITIVITY SYSTEM CHECK AND VERIFIED SERVICE ACTIVITY PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED SPECIFICATIONS AND DOCUMENTED IN THE CUSTOMER'S QC RECORD. THE CAUSE OF THE IMPRECISE ACCUTNI PATIENT RESULTS CANNOT BE DETERMINED WITH THE SUPPLIED INFORMATION AS THERE WAS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION. THE SYSTEM CHECK ISSUE REPORTED BY THE CUSTOMER WAS UNRELATED TO THE IMPRECISE ACCUTNI RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING IMPRECISE TROPONIN I (ACCESS ACCUTNI) RESULTS FOR ONE (1) PATIENT INVOLVING THE ACCESS 2 IMMUNOASSAY ANALYZER PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER OBTAINED AN INITIAL ACCUTNI RESULT WHICH WAS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF OF THE ASSAY FOR ONE (B)(6), MALE PATIENT. SUBSEQUENT REPEATS OF THE SAMPLE RECOVERED RESULTS WHICH WERE WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY AND WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY. THE CUSTOMER ALSO RAN THE SAMPLE USING AN ALTERNATE METHODOLOGY AND RECOVERED A NEGATIVE TROPONIN I RESULT. THE SAME PATIENT HAD A CREATININE KINASE (CK-MB) RESULT WHICH WAS NORMAL AT THE TIME THAT THE ACCUTNI RESULTS WERE OBTAINED. THE NORMAL CK-MB RESULT WAS REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO THE PATIENT'S TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER PERFORMED A SECOND DRAW ON THE SAME PATIENT SIX HOURS LATER AND OBTAINED ACCUTNI RESULTS WHICH WERE ABOVE THE AMI CUT-OFF OF THE ASSAY. QUALITY CONTROL (QC) RESULTS PRIOR TO THE EVENT WERE WITHIN THE ESTABLISHED RANGES. THE SAMPLE WAS COLLECTED IN A PLASMA SEPARATION TUBE (PST) AND CENTRIFUGED FOR 6 MINUTES AT 4000 RPM. THE ACCESS ACCUTNI REAGENT WAS USED IN CONJUNCTION WITH THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357008 ACCESS® ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 231303

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR