BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3073171 · Received April 23, 2013

    Report

    Report Number
    2122870-2013-00350
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE COLLECTED IN LITHIUM HEPARIN TUBES. CUSTOMER CENTRIFUGES SAMPLES FOR 5 MINUTES AT 3600 RPM. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CAUSE OF THE ERRATIC ACCUTNI AND CK-MB RESULTS COULD NOT BE DETERMINED WITH THE SUPPLIED INFORMATION.

    Description of Event or Problem · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE ON (B)(4) 2013 TO INVESTIGATE THE EVENT WHICH OCCURRED AT THE CUSTOMER SITE ON (B)(6) 2013 (DOCUMENTED IN MDR #: 2122870-2013-00407). THE FSE COLLECTED THE ARCHIVE DATA FILE FROM THE CUSTOMER AND SUPPLIED COMPLAINT INVESTIGATOR WITH THE FILE ON (B)(4) 2013. BASED ON THE INVESTIGATOR REVIEW OF THE ARCHIVED DATA, IT SHOWS THAT ERRATIC TROPONIN (ACCUTNI) AND CREATINE KINASE-MB (CKMB) PATIENT RESULTS OCCURRED ON OTHER DAYS AS WELL. THIS MDR REPORT IS BEING FILED FOR ERRATIC ACCUTNI RESULTS OBTAINED ON (B)(6) 2013 FOR ONE PATIENT SAMPLE. ACCUTNI RESULT FOR THE SAME PATIENT RECOVERED AT 0.31 NG/ML AND THE DUPLICATE RESULT WAS 0.54 NG/ML. THE REPEAT RESULT WAS 0.41 NG/ML. CUSTOMER RUNS ALL ACCUTNI SAMPLES IN DUPLICATE. CALIBRATION AND SYSTEM CHECK DATA WAS NOT SUPPLIED. QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES ON THE DATE OF THE EVENT. IT IS UNKNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT. THE CUSTOMER DID NOT SUPPLY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173630 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1