BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2880464 · Received December 19, 2012

    Report

    Report Number
    2122870-2012-02002
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER PROVIDED INFORMATION, THERE WAS NO ISSUE WITH QC RECOVERY. THE SAMPLE WAS COLLECTED INTO A PLASMA TUBE WITHOUT A GEL SEPARATOR AND WAS CENTRIFUGED AT 3000 RPMS FOR 5 MINUTES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO VERIFY HARDWARE PERFORMANCE IN RESPONSE TO THIS EVENT. THE FSE CONDUCTED A HIGH SENSITIVITY SYSTEM CHECK, WHICH WAS FAILING TO PASS WITHIN INSTRUMENT SPECIFICATIONS. THE FSE CLEANED THE WASH WHEEL, PERFORMED THE MIXER PULLEY MODIFICATION, REPLACED THE PERI PUMP TUBING, CLEANED THE INCUBATOR TRACK, RE-TENSIONED THE INCUBATOR BELT, CHECKED THE ULTRASONICS, CHECKED THE ASPIRATE AND DISPENSE PROBES, AND CLEANED THE WASH STATION. AFTER THE REPAIRS COMPLETION, THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, A SYSTEM CHECK, AND ALL LEVELS OF QC; ALL OF WHICH WERE FOUND TO BE PASSING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE FSE THEN RETURNED TO THE CUSTOMER SITE ON THE NEXT DAY TO REPLACE THE UNIVERSAL ROLLERS, INCUBATOR BELT, AND REACTION VESSELS (RV) CLIPS. A HIGH SENSITIVITY SYSTEM CHECK, SYSTEM CHECK, AND ALL LEVELS OF QC WERE THEN PERFORMED; ALL RESULTS WERE FOUND TO BE PASSING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE FSE WAS CALLED BY COMPLAINT INVESTIGATOR ON (B)(6) 2012 TO DETERMINE IF HE FELT THERE WERE ANY HARDWARE MALFUNCTIONS WHICH MAY HAVE CAUSED, OR CONTRIBUTED TO, THIS EVENT. THE FSE STATED ALL REPAIRS WERE PERFORMED IN RESPONSE TO THE FAILING HIGH SENSITIVITY SYSTEM CHECK; HOWEVER, HE FELT THERE WERE NO HARDWARE MALFUNCTIONS THAT CAUSED, OR CONTRIBUTED TO, THE EVENT. UPON FURTHER REVIEW OF ALL SUPPLIED DATA, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE A DEFINITIVE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A BECKMAN COULTER INC., (BEC) FIELD SERVICE ENGINEER (FSE) WAS ON SITE FOR A SEPARATE ISSUE AND CUSTOMER REPORTED TO THE FSE THAT THEY OBTAINED ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS ON 2 PATIENTS, ON 2 SEPARATE DATES, USING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM. THE FSE FILED A COMPLAINT ON BEHALF OF THE CUSTOMER. THIS MDR IS TO REPORT AN EVENT WHICH OCCURRED ON (B)(6) 2012. A PATIENT SAMPLE WAS TESTED FOR ACCUTNI AND A RESULT OBTAINED WAS WITHIN THE RISK STRATIFICATION RANGE. THE CUSTOMER REPORTED TO THE ON-SITE FSE THAT THEY HAVE A "REPEAT PROTOCOL" IN PLACE TO REPEAT ANY PATIENT SAMPLES THAT HAVE ACCUTNI RESULTS GREATER THAN 0.05NG/ML. UPON REPEAT ANALYSIS, THE PATIENT SAMPLE GAVE AND AN ACCUTNI RESULT WITHIN THE NORMAL REFERENCE RANGE. PATIENT RESULTS VERBALLY PROVIDED BY THE CUSTOMER ARE SHOWN IN THIS REPORT. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER SUSPECTS THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ERRONEOUSLY ELEVATED ACCUTNI; HOWEVER, THE CUSTOMER WAS UNABLE TO CONFIRM HOSPITAL ADMISSION. MDR#: 2122870-2012-02003 IS BEING SUBMITTED TO REPORT AN EVENT OCCURRED ON (B)(6) 2012 AT THIS CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization