BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 4490335 · Received February 6, 2015

    Report

    Report Number
    2122870-2015-00078
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    December 20, 2014
    Report Date
    January 13, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121790
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INVESTIGATION IT WAS DISCOVERED THAT THE SERIAL NUMBER OF THE CUSTOMER'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM WAS INACCURATELY REPORTED TO BECKMAN COULTER (BEC). THE SERIAL NUMBER IS UNKNOWN. THE CUSTOMER'S SITE HAS TWO UNICEL DXI 600 IMMUNOASSAY SYSTEMS (900984 AND 900983). IF FURTHER INFORMATION IS RECEIVED BEC WILL UPDATE WITH FOLLOW-UP REPORTS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS: AGE, DATE OF BIRTH, SEX OR WEIGHT. THE CUSTOMER DID NOT SUPPLY THE ACCESS ACCUTNI+3 REAGENT LOT NUMBER, EXPIRATION DATE OR DATE OF MANUFACTURE. THE ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE NON-REPRODUCIBLE ELEVATED ACCESS ACCUTNI+3 RESULTS CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. ALL MDRS ASSOCIATED WITH THIS REPORT ARE: 2122870-2015-00078, 2122870-2015-00079, 2122870-2015-00080, 2122870-2015-00081, 2122870-2015-00082, 2122870-2015-00083, 2122870-2015-00084, 2122870-2015-00085, 2122870-2015-00086, 2122870-2015-00087, 2122870-2015-00088, 2122870-2015-00089, 2122870-2015-00090, 2122870-2015-00091. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS ON THEIR UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER UNKNOWN).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS ON THEIR UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR A TOTAL OF TWENTY SEVEN PATIENTS OCCURRING ACROSS 14 DAYS. THIS REPORT ADDRESSES TWO ELEVATED PATIENT RESULTS OBTAINED ON (B)(6) 2014. THE INITIAL ELEVATED PATIENTS' RESULTS WERE ABOVE THE CUSTOMER'S NORMAL REFERENCE RANGE. THESE ELEVATED RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. PER THE LABORATORY'S REPEAT PROTOCOL, ANY RESULT OBTAINED ABOVE THE NORMAL REFERENCE RANGE, IS ALIQUOTED, CENTRIFUGED AND REANALYZED IN DUPLICATE. THE PATIENTS' SAMPLES WERE REANALYZED IN DUPLICATE ON THE SAME UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM AND RECOVERED WITHIN THE CUSTOMER'S NORMAL REFERENCE RANGE. THE REANALYZED, LOWER RESULTS WERE RELEASED FROM THE LABORATORY. CALIBRATION, SYSTEM CHECK, AND QUALITY CONTROL (QC) DATA WAS NOT SUPPLIED. THE CUSTOMER DID STATE THAT QC HAS BEEN PERFORMING WITHIN SPECIFICATIONS. THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN PLASMA TUBES. CENTRIFUGATION SPEED, TEMPERATURE AND TIME WERE NOT SUPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86838 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT, PRODUCT CODE MMI MMI BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1