BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI

    MDR report key: 3903611 · Received June 30, 2014

    Report

    Report Number
    2122870-2014-00486
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    : THERE IS NO INDICATION THAT THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER SUPPLIED TWO PATIENT SAMPLES FOR FURTHER ANALYSIS. THE PATIENT SAMPLES WERE FIRST TESTED NEAT AFTER CENTRIFUGATION AND ELEVATED TROPONIN I RESULTS WERE OBTAINED. INTERFERENCE TESTING FOLLOWED, USING A MIX OF DIFFERENT BLOCKERS, WHICH DEMONSTRATED THE PRESENCE OF INTERFERING SUBSTANCES SINCE AT LEAST ONE OF THE BLOCKERS USED IN THE TEST SIGNIFICANTLY LOWERED THE SIGNAL. IN CONCLUSION, INTERFERENCE, RELATED TO ALKALINE-PHOSPHATASE, IS THE CAUSE OF THE FALSELY ELEVATED TROPONIN I RESULTS. PER THE PRODUCT INSTRUCTIONS FOR USE (IFU): FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HAMA, THAT INTERFERES WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES. OTHER POTENTIAL INTERFERENCES IN THE PATIENT SAMPLE COULD BE PRESENT AND MAY CAUSE ERRONEOUS RESULTS IN IMMUNOASSAYS. SOME EXAMPLES THAT HAVE BEEN DOCUMENTED IN LITERATURE INCLUDE RHEUMATOID FACTOR, ENDOGENOUS ALKALINE PHOSPHATASE, FIBRIN, AND PROTEINS CAPABLE OF BINDING TO ALKALINE PHOSPHATASE. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE TYPES OF INTERFERENCES.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED FALSELY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI ASSAY USED IN CONJUNCTION WITH THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. INITIAL RESULTS OF 34.6 NG/ML AND 34.6 NG/ML WERE OBTAINED. TESTING OF ADDITIONAL SAMPLES, ON AN ALTERNATE UNICEL DXI 600 SYSTEM, ALSO PRODUCED ELEVATED RESULTS. THE CUSTOMER STATED THE INITIAL RESULTS WERE RELEASED OUT OF THE LABORATORY. AS A RESULT, THE PATIENT WAS HOSPITALIZED FOR SEVERAL DAYS AND RECEIVED A CORONAROGRAPHY, WHICH PRODUCED A NEGATIVE RESULT. ADDITIONAL TESTING OF THE SAMPLES, ON AN ALTERNATE METHODOLOGY, PRODUCED NEGATIVE RESULTS. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER INDICATED QUALITY CONTROL (QC) PERFORMED WITHIN SPECIFICATION AT THE TIME OF THE EVENT. NO SYSTEM ISSUES WERE NOTED. THE CUSTOMER SUPPLIED BECKMAN COULTER WITH THE PATIENT'S SAMPLES FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379203 ACCESS ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 336053

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| O