BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 4884400 · Received July 1, 2015

    Report

    Report Number
    2122870-2015-00404
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 26, 2015
    Report Date
    June 9, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121790
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE. THERE IS NO EVIDENCE THAT THE ACCESS ACCUTNI+3 REAGENT WAS RETURNED FOR EVALUATION. THE MARSEILLE COMPLAINT HANDLING UNIT (CHU) PERFORMED BOTH INTERFERENCE TESTING AND GEL FILTRATION CHROMATOGRAPHY (GFC) TESTING ON THE PATIENT'S SAMPLES. THE INTERFERENCE TESTING DID NOT DETECT EITHER A PATIENT SOURCE HETEROPHILIC OR ALKALINE PHOSPHATASE INTERFERENT IN THE PATIENT'S SAMPLES. GFC TESTING CONFIRMED THAT TROPONIN I WAS PRESENT IN THE PATIENT'S SAMPLES AND DID REACT ACCORDINGLY WITH THE ACCESS ACCUTNI+3 ASSAY. IN CONCLUSION, PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THE ERRATIC ACCESS ACCUTNI+3 RESULTS OBTAINED BY THE CUSTOMER AS RE-CENTRIFUGATION OF THE SAMPLES GENERATED REPRODUCIBLE RESULTS. THE ACTUAL CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. ALL MDRS ASSOCIATED WITH THIS EVENT: MDR 2122870-2015-00404, MDR 2122870-2015-00405, MDR 2122870-2015-00406, MDR 2122870-2015-00407.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE (1) PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ((B)(4)). THE INITIAL ACCESS ACCUTNI+3 RESULT WAS ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE (DESIGNATED AS SAMPLE 1) ONE (1) ADDITIONAL TIME ON THE SAME UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND OBTAINED A HIGHER RESULT ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. THIS SAMPLE (SAMPLE 1) WAS THEN RE-CENTRIFUGED AND ANALYZED AN ADDITIONAL TWO (2) TIMES ON THE SAME UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER OBTAINED REPRODUCIBLE, LOWER RESULTS WHICH WERE STILL ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. A SECOND SAMPLE FROM THE PATIENT (DESIGNATED AS SAMPLE 2) WAS ALSO ANALYZED ON THE SAME DATE ((B)(6) 2015) AND ON THE SAME UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND AN ELEVATED ACCESS ACCUTNI+3 RESULT WAS OBTAINED WHICH WAS ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. THIS SAMPLE (SAMPLE 2) WAS REANALYZED ONE (1) ADDITIONAL TIME AND A SIMILAR RESULT, ABOVE THE ASSAY'S NORMAL REFERENCE RANGE, WAS OBTAINED. THIS SAMPLE (SAMPLE 2) WAS THEN RE-CENTRIFUGED AND ANALYZED AN ADDITIONAL TWO (2) TIMES ON THE SAME UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER OBTAINED REPRODUCIBLE, LOWER RESULTS WHICH WERE STILL ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. THE INITIAL, ELEVATED ACCUTNI+3 RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. MDR 2122870-2015-00405 WILL ADDRESS THE ERRATIC ACCESS ACCUTNI+3 RESULTS OBTAINED ON (B)(6) 2015 FOR THIS PATIENT. MDR 2122870-2015-00406 WILL ADDRESS THE ERRATIC ACCESS ACCUTNI+3 RESULTS OBTAINED ON (B)(6) 2015 FOR THIS PATIENT ON THE LABORATORY'S ALTERNATE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ((B)(4)) AND MDR 2122870-2015-00407 WILL ADDRESS THE ERRATIC ACCESS ACCUTNI+3 RESULTS OBTAINED ON (B)(6) 2015 FOR THIS PATIENT ON THE LABORATORY'S ALTERNATE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. CALIBRATION, QC (QUALITY CONTROL) AND SYSTEM CHECK PARAMETERS WERE ALL RECOVERING WITHIN EXPECTED RANGES AT THE TIME OF THE EVENT. THE PATIENT'S SAMPLES WERE COLLECTED IN HEPARIN PLASMA TUBES. THE CUSTOMER DID NOT PROVIDE PROCESSING INFORMATION SUCH AS CENTRIFUGATION TIME AND SPEED. NO ISSUES WITH SAMPLE INTEGRITY, HARDWARE ERRORS OR SAMPLE FLAGS WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424764 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 434885

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR