BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGG

    MDR report key: 11215388 · Received January 22, 2021

    Report

    Report Number
    9680746-2021-00009
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    January 5, 2021
    Report Date
    January 22, 2021
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKO
    UDI-DI
    15099590738648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILL PATIENT IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGG REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES 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. A CAUSE FOR THIS EVENT COULD NOT BE DETERMINED WITH THE INFORMATION SUPPLIED. THE CUSTOMER REFUSED TO INVESTIGATE. IN CONCLUSION THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER REPORTED ONE DISCORDANT NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 971198) RESULT WAS GENERATED FOR ONE PATIENT ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE NON-REACTIVE ACCESS SARS-COV-2 IGG PATIENT RESULT (0.6 S/CO) WAS DISCORDANT WITH THE VIDAS SARS-COV-2 IGG RESULT (2.5=REACTIVE). THE PATIENT HAD A POSITIVE PCR BETWEEN (B)(6) 2020. THE CUSTOMER DOES NOT WANT TO INVESTIGATE AND HE HAS REPORTED THE VIDAS DATA. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. PASSING SYSTEM CHECKS WERE OBTAINED ON (B)(6) 2021. CALIBRATION PASSED ON (B)(6) 2020 WITH REAGENT LOT 971198 AND CALIBRATOR LOT 988703. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, CENTRIFUGATION, STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111816 ACCESS SARS-COV-2 IGG IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO CLARE DISCRETE MFG IO 971198 15099590738648

    Patients

    Seq Age Sex Outcome Treatment
    1