BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY ANALYZER

    MDR report key: 11457543 · Received March 10, 2021

    Report

    Report Number
    9680746-2021-00021
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 10, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265380
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE WERE NOT PROVIDED. (B)(6). A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE REPLACED THE PRECISION PUMP, WHICH RESOLVED THE ISSUE. FSE ALSO ADJUSTED PRESSURE SENSOR AND TRANSDUCER. FSE PERFORMED A PRECISION STUDY WHICH GENERATED RESULTS WITHIN EXPECTATIONS. FSE VERIFIED INSTRUMENT PERFORMANCE AND NO FURTHER ISSUES WERE NOTED. IN CONCLUSION, THE CAUSE OF THIS EVENT IS A HARDWARE MALFUNCTION.

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED THAT REACTIVE RESULTS FOR 20 PATIENTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (ACCESS) (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR THE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM, PART NUMBER C58957 AND LOT NUMBER 971287). THE SAMPLES WERE REPEAT TESTED ON AN ALTERNATE DXI INSTRUMENT AT AN EXTERNAL LABORATORY (INSTRUMENT PART NUMBER AND SERIAL NOT PROVIDED) AND RESULTS OBTAINED FROM THE DXI WERE NON-REACTIVE. CUSTOMER DID NOT PROVIDE PATIENT RESULTS FOR REVIEW. THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THE EVENT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THE EVENT. SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS. THE CUSTOMER DID NOT PROVIDE QUALITY CONTROL DATA FOR REVIEW. A CALIBRATION HAD FAILED ON (B)(6) 2021 DUE TO NO FIT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION AND HANDLING INFORMATION SUCH AS SAMPLE TYPE, COLLECTION TUBE TYPE AND MANUFACTURER, CLOT TIME (IF APPLICABLE), CENTRIFUGATION TIME, SPEED AND TEMPERATURE WERE NOT PROVIDED BY THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) (LOCAL SUPPORT) WAS DISPATCHED TO THE SITE TO ASSESS INSTRUMENT PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349923 ACCESS 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER 15099590265380

    Patients

    Seq Age Sex Outcome Treatment
    1