BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGG

    MDR report key: 10986201 · Received December 10, 2020

    Report

    Report Number
    2122870-2020-00096
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    December 8, 2020
    Report Date
    December 10, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FULL PATIENT IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE CUSTOMER DID NOT PROVIDE A ACCESS SARS-COV-2 IGG ASSAY LOT NUMBER; THEREFORE, THE DATE OF MANUFACTURE AND THE UDI COULD NOT BE DETERMINED. THE CUSTOMER DID NOT PROVIDE A ACCESS SARS-COV-2 IGG ASSAY LOT NUMBER; THEREFORE, THE DATE OF EXPIRATION COULD NOT BE DETERMINED. 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. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THE EVENT. THE REPORTED ISSUE WAS DUE TO A FAILURE OF THE LABORATORY INFORMATION SYSTEM (LIS). THE LIS VENDOR RESOLVED THE ISSUE BY CHANGING INTERPRETATION IN PATIENT RESULTS IN THE LIS. THERE IS NO MALFUNCTION OF THE SARS-COV-2 IGG ASSAY. BECKMAN COULTER DOES NOT DESIGN, MANUFACTURE OR DISTRIBUTE LIS SYSTEMS. THERE IS NO MALFUNCTION OR NONCONFORMANCE IDENTIFIED WITH THE BECKMAN COULTER INSTRUMENT OR ASSAY. THE LIS IS A THIRD PARTY PARTNER PRODUCT INTERFACING WITH BECKMAN COULTER SYSTEMS; THE LIS COMPANY HAS OPENED A CASE TO INVESTIGATE THIS ISSUE. IN CONCLUSION, THERE WAS NO MALFUNCTION IDENTIFIED WITH THE BECKMAN COULTER ACCESS SARS-COV-2 IGG ASSAY. THE LIS IS A THIRD PARTY PARTNER PRODUCT INTERFACING WITH BECKMAN COULTER SYSTEMS.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER REPORTED THAT RESULTS GENERATED ON THE CUSTOMER'S UNICEL DXX 800 ACCESS IMMUNO ANALYZER (DXI) (PART NUMBER: 973100 AND SERIAL NUMBER: (B)(4)) FOR THE SARS-COV -2 IGG (ACCESS SARS-COV-2 IGG, PART NUMBER: C58961) WERE REPORTED AS 'NON-REACTIVE' INSTEAD OF 'EQUIVOCAL.' THE LABORATORY INFORMATION SYSTEM (LIS) REPORTED GRAY ZONE RESULTS AS 'NON-REACTIVE' INSTEAD OF 'EQUIVOCAL.' THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THE EVENT. THE CUSTOMER PROVIDED TWO PATIENT RESULTS. SEE FOLLOWING "RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES" SECTION FOR DETAILS. NO HARDWARE ERRORS, OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THE EVENT. THE CUSTOMER DID NOT PROVIDE SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATIONS, OR QUALITY CONTROL (QC) DATA FOR REVIEW. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450317 ACCESS SARS-COV-2 IGG IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO BECKMAN COULTER

    Patients

    Seq Age Sex Outcome Treatment
    1