BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNL+3 REAGENT

    MDR report key: 3920306 · Received July 8, 2014

    Report

    Report Number
    2122870-2014-00488
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO PERFORM A PRECISION RUN. THE CUSTOMER STARTED THE PRECISION RUN, BUT STOPPED AFTER A CLICKING NOISE WAS HEARD FROM THE INSTRUMENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND DETERMINED THE RATTLING WAS DUE THE FAN OF THE INSTRUMENT AND REPLACED THE PART. THE FSE DID NOT NOTE ANY INSTRUMENT MALFUNCTION THAT WOULD CAUSE NON-REPRODUCIBLE ACCUTNI+3 RESULTS. THE FSE PROACTIVELY DECONTAMINATED THE SUBSTRATE SUBSYSTEM. (B)(4). ASSOCIATED MDR: 2122870-2014-00487.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ACCESS 2 IMMUNOASSAY SYSTEM OF A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM HAD GENERATED NON-REPRODUCIBLE, ELEVATED TROPONIN I (ACCUTNI+3) RESULTS. THE ACCUTNI+3 RESULTS WERE QUESTIONED BY THE PHYSICIANS BECAUSE THE ELEVATED RESULTS DID NOT MATCH THE CLINICAL PICTURES OF THE PATIENTS. THE CUSTOMER SUSPECTED THERE HAD BEEN EIGHTEEN (18) NON-REPRODUCIBLE ACCUTNI+3 PATIENT RESULTS GENERATED ON (B)(6) 2014. REVIEW OF THE CUSTOMER SUPPLIED PATIENT RESULTS AND THE INSTRUMENT'S ARCHIVED DATA FILE IDENTIFIED TWELVE (12) NON-REPRODUCIBLE ACCUTNI+3 PATIENT RESULTS GENERATED ON (B)(6) 2014. THIS MDR REPORTS THE RESULTS OBTAINED ON (B)(6) 2014 IN WHICH THERE WAS A CHANGE TO TREATMENT; ON (B)(6) 2014, ELEVATED ACCUTNI+3 RESULTS WERE GENERATED FOR THREE (3) PATIENTS AND THE PATIENTS WERE ADMITTED TO THE HOSPITAL AS A RESULT. THE PATIENT SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND ON AN ALTERNATE INSTRUMENT; LOWER ACCUTNI+3 RESULTS WERE GENERATED AND THE RESULTS WERE CORRECTED. QUALITY CONTROL (QC) RESULTS WERE WITHIN RANGE ON THE DATES OF THE EVENT. ACCUTNI+3 REAGENT WAS CALIBRATED ON (B)(6) 2014 WITH ACCUTNI+3 CALIBRATOR LOT 330252. THE INSTRUMENT HAD PASSED SYSTEM CHECK ON (B)(6) 2014. THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN GEL TUBES AND SERUM SEPARATOR TUBES; THE SAMPLES WERE CENTRIFUGED IN A STAT SPIN AT AN UNKNOWN SPEED FOR FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398211 ACCESS ACCUTNL+3 REAGENT IMMUNOASSAY METHOD, TROPONIN MMI BECKMAN COULTER NA 325487

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization