BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2122870-2016-00090

    MDR report key: 5448464 · Received February 19, 2016

    Report

    Report Number
    2122870-2016-00090
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 25, 2016
    Report Date
    January 25, 2016
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS SUCH AS: AGE, DATE OF BIRTH, SEX AND WEIGHT WERE NOT PROVIDED BY THE CUSTOMER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS INSTRUMENT PERFORMANCE. WHILE ON SITE THE FSE REPLACED THE SAMPLE PIPETTOR, PERFORMED ALIGNMENTS AND CALIBRATED ALL OF THE PRESSURE SENSORS. AFTER THE REPAIRS WERE COMPLETE, ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED INSTRUMENT AND ASSAY PERFORMANCE SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THE NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULTS WAS A HARDWARE MALFUNCTION OF THE SAMPLE PIPETTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULTS INVOLVING THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) FOR SEVEN (7) PATIENTS. THE ELEVATED ACCESS ACCUTNI+3 SAMPLES FOR PATIENTS ONE (1) THROUGH FOUR (4) WERE REPEATED ON THE SAME UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM AND LOWER OR EQUAL RESULTS WERE OBTAINED, BOTH WITHIN AND OUTSIDE OF THE ASSAY'S NORMAL REFERENCE RANGE. THE SAMPLES WERE ALL THEN TESTED ON THE LABORATORY'S ALTERNATE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER 901077 AND LOWER RESULTS, WITHIN THE ASSAY'S NORMAL REFERENCE RANGE, WERE OBTAINED. THE SAMPLES FOR PATIENTS FIVE (5) THROUGH SEVEN (7) WERE REPEATED ON THE LABORATORY'S ALTERNATE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) AND LOWER RESULTS, BOTH WITHIN AND OUTSIDE OF THE ASSAY'S NORMAL REFERENCE RANGE, WERE OBTAINED. THE ORIGINAL ELEVATED RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH THE NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULTS. QUALITY CONTROL (QC) RUN AFTER THE GENERATION OF THE NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULTS DID NOT RECOVER WITHIN CUSTOMER ESTABLISHED RANGES. CALIBRATION WAS PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLE INFORMATION WAS NOT PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE NOTED BY THE CUSTOMER. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS INSTRUMENT PERFORMANCE.

    Patients

    Seq Age Sex Outcome Treatment
    1