BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI REAGENT

    MDR report key: 5953487 · Received September 15, 2016

    Report

    Report Number
    2122870-2016-00445
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    July 25, 2016
    Report Date
    August 25, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121790
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE ACCESS INSTRUMENT MODEL NUMBER IN USE AT THE TIME OF THIS EVENT COULD NOT BE IDENTIFIED BY THE CUSTOMER, THE ACCESS ACCUTNI+3 REAGENT CATALOG NUMBER COULD NOT BE CONFIRMED, THE ACCESS ACCUTNI+3 REAGENT CATALOG NUMBER IS EITHER A98264 OR A98143. THE ACCESS ACCUTNI+3 REAGENT LOT NUMBER WAS NOT SUPPLIED, THEREFORE THE EXPIRATION DATE AND MANUFACTURE DATE COULD NOT BE DETERMINED. THE ACCESS INSTRUMENT MODEL NUMBER IN USE AT THE TIME OF THIS EVENT COULD NOT BE IDENTIFIED BY THE CUSTOMER, THEREFORE; THE PMA/510(K) NUMBER CANNOT BE CONFIRMED. THE PMA/510(K) NUMBER IS EITHER K121214 OR K121790. THE ACCESS ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS INSTRUMENT PERFORMANCE. WHILE ON SITE THE FSE CLEANED THE ASPIRATE PROBES AND THE WASH STATIONS AND NOTED NO ISSUES. THE FSE ALSO PERFORMED A CARRYOVER TEST, HIGH SENSITIVITY (HS) SYSTEM CHECK, RAN A 50 REPLICATE PRECISION RUN USING WASH BUFFER AS A SAMPLE AND PERFORMED A 20 REPLICATE PRECISION RUN WITH EACH OF 3 LEVELS OF QC; ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED INSTRUMENT AND ASSAY PERFORMANCE SPECIFICATIONS. CONCLUSION: IN CONCLUSION, THE CAUSE OF THE ERRONEOUSLY ELEVATED ACCESS ACCUTNI+3 RESULTS CANNOT BE DETERMINED. ALL MDRS ASSOCIATED WITH THIS REPORT ARE: 2122870-2016-00445; 2122870-2016-00446.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER ON AUGUST 25, 2016 TO REPORT GENERATING REPRODUCIBLY ELEVATED ACCESS ACCUTNI+3 RESULTS FOR ONE PATIENT ON EITHER THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) OR THE ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). THE CUSTOMER COULD NOT PROVIDE INFORMATION ON WHICH ANALYZER WAS IN USE FOR THIS EVENT. THIS RESULT WAS OBTAINED ON (B)(6) 2016. THE SAME PATIENT'S SAMPLE WAS ALSO ANALYZED ON AN ALTERNATE METHODOLOGY, ABBOTT I-STAT AND A NORMAL RESULT WAS OBTAINED. THE ACCESS ACCUTNI+3 RESULT WAS RELEASED FROM THE LABORATORY. THERE WAS CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH THE REPRODUCIBLY ELEVATED ACCESS ACCUTNI+3 RESULT, AS THE PATIENT UNDERWENT A CARDIAC CATHETERIZATION. THE CUSTOMER NOTED THE RESULTS OF THE CARDIAC CATHETERIZATION WERE NORMAL. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS INSTRUMENT PERFORMANCE. QUALITY CONTROL (QC) AND CALIBRATION WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA SEPARATOR TUBE AND CENTRIFUGED AT 3000 RPM (REVOLUTIONS PER MINUTE) FOR FIVE MINUTES AT ROOM TEMPERATURE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED. THE CUSTOMER ALSO REPORTED ANOTHER ERRONEOUSLY ELEVATED ACCESS ACCUTNI+3 RESULT OBTAINED ON (B)(6) 2016 FOR A SECOND PATIENT'S SAMPLE. THIS EVENT IS ADDRESSED IN MDR 2122870-2016-00446.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606202 ACCESS ACCUTNI REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other