BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGG ASSAY

    MDR report key: 11630891 · Received April 7, 2021

    Report

    Report Number
    2122870-2021-00044
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 7, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    QKO
    UDI-DI
    15099590738648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL IDENTIFIER IS CASE (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGG ASSAY WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF SYSTEM ISSUES AT THE TIME OF THE EVENT. ALL ASSAY AND SYSTEM VERIFICATIONS MET SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THE EVENT. THE ABBOTT ALINITY ASSAY ALSO DETECTS ANTIBODIES DIRECTED AGAINST THE SPIKE PROTEIN. THE ROCHE ASSAY IS A TOTAL ASSAY, DETECTING IGG, IGM AND IGA WITHOUT DISTINCTION. THE RESULTS OF A TOTAL ASSAY CANNOT BE COMPARED TO THE RESULTS OF AN IGG-ONLY ASSAY. IT IS UNKNOWN WHICH ROCHE ASSAY (ANTI-SPIKE VERSUS ANTI-NUCLEOPROTEIN) WAS USED. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED NEGATIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 922776) WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) FOR AN TWO SAMPLES FROM ONE PATIENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT SAMPLE HAD GENERATED REACTIVE RESULTS WITH TWO DIFFERENT SARS-COV-2 ASSAYS: THE ROCHE SARS-COV-2 AB ASSAY AND THE ABBOTT ALINITY SARS-COV-2 IGG ASSAY. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527264 ACCESS SARS-COV-2 IGG ASSAY IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO BECKMAN COULTER 922776 15099590738648

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR