BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 6141661 · Received December 2, 2016

    Report

    Report Number
    2122870-2016-00561
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590209322
    PMA / PMN Number
    K121214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUPPLY ANY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX OR WEIGHT THE BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) DISPATCHED TO THE CUSTOMER SITE DID NOT IDENTIFY ANY MALFUNCTION AS HAVING CAUSED THE GENERATION OF THE ERRONEOUS RESULTS. PERFORMANCE INDICATORS FOR THE SYSTEM WERE ACCEPTABLE BEFORE AND AFTER THIS EVENT. THERE IS NO EVIDENCE THAT THE ACCESS ACCUTNI+3 WAS RETURNED FOR EVALUATION. IN CONCLUSION, A DEFINITIVE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. ALL MDRS ASSOCIATED WITH THIS REPORT ARE: 2122870-2016-00560; 2122870-2016-00561. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE THREE (3) ADDITIONAL TIMES ON THE SAME ACCESS 2 IMMUNOASSAY SYSTEM AND OBTAINED LOWER RESULTS, WITHIN THE ASSAY'S NORMAL REFERENCE RANGE. THE ELEVATED ACCESS ACCUTNI+3 RESULT WAS NOT RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THIS MDR ADDRESSES THE ELEVATED ACCESS ACCUTNI+3 RESULT OBTAINED ON (B)(6) 2016. MFR #2122870-2016-00560 ADDRESSES THE ELEVATED ACCESS ACCUTNI+3 RESULT OBTAINED ON (B)(6) 2016. CALIBRATION, QC (QUALITY CONTROL) AND SYSTEM CHECK PARAMETERS WERE ALL RECOVERING WITHIN EXPECTED RANGES AT THE TIME OF THE EVENT. ONE ERRONEOUSLY HIGH QC LEVEL 1 RESULT WAS OBTAINED AFTER THE EVENT, IT WAS REPEATED WITHIN SPECIFICATIONS. THE PATIENT'S SAMPLE WAS COLLECTED IN A PLASMA SEPARATION TUBE AND WAS CENTRIFUGED FOR FIVE (5) MINUTES AT 3,500 RPM (ROTATIONS PER MINUTE) AT ROOM TEMPERATURE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS INSTRUMENT PERFORMANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791125 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 624362 15099590209322

    Patients

    Seq Age Sex Outcome Treatment
    1