BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 3100856 · Received May 8, 2013

    Report

    Report Number
    2122870-2013-00447
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING ON THE FOUR PATIENT SAMPLES PROVIDED REVEALED THE PRESENCE OF A PATIENT SOURCED INTERFERENT LIKELY RELATED TO ALKALINE PHOSPHATASE. ACCUTNI REAGENT'S INSTRUCTIONS FOR USE (IFU) WARNS CUSTOMERS OF POTENTIAL INTERFERENCES IN PATIENT SAMPLES WHICH COULD CAUSE ERRONEOUS RESULTS IN IMMUNOASSAYS. THE IFU ADVISES CUSTOMERS TO CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING INTERFERENCES. THE CAUSE OF THE REPRODUCIBLE ELEVATED ACCUTNI RESULTS IS DUE TO A PATIENT SOURCED INTERFERENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE ELEVATED ACCESS ACCUTNI (TROPONIN I) PATIENT RESULTS INVOLVING THE ACCESS 2 IMMUNOASSAY ANALYZER. THE CUSTOMER INDICATED THAT FOUR (4) SEPARATE DRAWS FROM ONE (1) PATIENT RECOVERED ACCUTNI RESULTS WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY. THE ELEVATED ACCUTNI RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS CATHETERIZED AS A RESULT OF THE ELEVATED RESULTS. THE CUSTOMER ALSO OBTAINED CK-MB (CREATININE KINASE) AND BNP (B-TYPE NATRIURETIC PEPTIDE) RESULTS WHICH WERE WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAYS. THE CUSTOMER REPEATED THE SAMPLES ON AN ALTERNATE METHODOLOGY AND OBTAINED NEGATIVE RESULTS FOR THE FOUR SAMPLES. THE PATIENT WAS DISCHARGED AND THE CUSTOMER SENT ALL FOUR PATIENT SAMPLES TO BECKMAN COULTER FOR TESTING. CALIBRATIONS AND SYSTEM CHECKS PASSED WITHIN SPECIFICATIONS AND QC (QUALITY CONTROL) WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES ON THE DATE OF THE EVENT. THE SAMPLES WERE COLLECTED IN SODIUM HEPARIN TUBES AND CENTRIFUGED IN A STAT SPIN. ACCESS ACCUTNI REAGENT LOT NUMBERS 229174 AND 231031 WERE USED IN CONJUNCTION WITH THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201957 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other