BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® ACCUTNI+3 REAGENT

    MDR report key: 3760231 · Received April 18, 2014

    Report

    Report Number
    2122870-2014-00279
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS ACCUTNI+3 DEVICE WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) NOTED THE TRANSDUCER VOLTAGE WOULD NOT ADJUST TO SPECIFICATIONS AND REPLACED THE TRANSDUCER. THE FSE PROACTIVELY CLEANED THE INCUBATOR TRACK AND WASH WHEEL. THE FSE PROACTIVELY REBUILT THE PRECISION PUMP AND WASH PUMP AND REPLACED THE SEALS. THE FSE PROACTIVELY CLEANED THE PRECISION AND WASH PUMP VALVES AND REPLACED THE PERISTALTIC PUMP TUBING. THE FSE COMPLETED A SUCCESSFUL SYSTEM CHECK, QUALITY CONTROL, AND 10-REPLICATE PRECISION TEST UTILIZING LEVEL 1 QUALITY CONTROL (QC). SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN SUMMARY, A FAULTY TRANSDUCER WOULD LIKELY LEAD TO ERRONEOUSLY LOW RESULTS INSTEAD OF ERRONEOUSLY ELEVATED VALUES. THERE WAS NO EVIDENCE TO REASONABLY SUGGEST A SYSTEM MALFUNCTION. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00278; 2122870-2014-00279; 2122870-2014-00280.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS, FOR THREE PATIENTS, INVOLVING THE ACCESS ACCUTNI+3 REAGENT USED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT IS TWO OF THREE REFERENCING THE PATIENT ON THE EVENT DATE NOTED. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. CONSEQUENTLY, THE PATIENT WAS TAKEN TO THE CATHETERIZATION LABORATORY AND HAD DIAGNOSTIC CATHETERIZATION PERFORMED. THE CUSTOMER STATED STENTS WERE NOT DEPLOYED AS A RESULT OF THE CATHETERIZATION. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE, ON AN ALTERNATE UNICEL DXC 600I INSTRUMENT, AND OBTAINED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER STATED AN AMENDED REPORT WAS ISSUED TO THE HOSPITAL. THE CUSTOMER INDICATED SYSTEM CHECK AND QUALITY CONTROL (QC) WERE WITHIN SPECIFICATIONS ON THE DAY OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236883 ACCESS® ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 325487

    Patients

    Seq Age Sex Outcome Treatment
    1 Other