BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGM

    MDR report key: 11359284 · Received February 22, 2021

    Report

    Report Number
    9680746-2021-00019
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 6, 2021
    Report Date
    February 22, 2021
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKO
    UDI-DI
    15099590738617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGM REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE THE SAMPLES OR ADDITIONAL INFORMATION FOR INVESTIGATION. NO MANUFACTURER GUARANTEES BOTH A SPECIFICITY AND SENSITIVITY OF 100%. DIFFERENCES IN EACH INDIVIDUAL ASSAY ARE EXPECTED. THE ABBOTT ASSAYS DETECT ANTIBODIES DIRECTED AGAINST THE NUCLEOCAPSID OF THE VIRUS WHILE THE ACCESS ASSAYS DETECT ANTIBODIES DIRECTED AGAINST THE SPIKE PROTEIN, WHICH ARE MORE LIKELY TO NEUTRALIZE THE VIRUS. SOME PATIENT MAY DEVELOP ANTIBODIES DIRECTED ONLY AGAINST THE NUCLEOPROTEINS AND NOT AGAINST THE SPIKE PROTEIN AND VICE VERSA, WHICH MAY EXPLAIN SOME DIFFERENCES IN RESULTS. 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 · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971287) RESULTS WERE GENERATED FOR ONE PATIENT ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE ACCESS SARS-COV-2 IGM RESULTS OBTAINED FOR THE PATIENT WERE 0.34 S/CO ON (B)(6) 2021 AND 0.31 S/CO ON (B)(6) 2021. PER CUSTOMER VERBAL'S REPORT, THE ACCESS RESULTS WERE DISCORDANT WITH REACTIVE ABBOTT RESULTS (ABBOTT PATIENT DATA WAS NOT PROVIDED). THE PATIENT HAD ALSO NON-REACTIVE ACCESS SARS-COV-2 IGG RESULTS. THE PATIENT EXPERIENCED FLU SYMPTOMS IN (B)(6) 2020. THERE WERE NO PCR RESULTS AVAILABLE. 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. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON (B)(6) 2021 AND CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 971287 AND CALIBRATOR LOT 922426. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE INFORMATION SUCH AS SAMPLE COLLECTION TUBE USED, CENTRIFUGATION TIME AND SPEED, STORAGE OR HANDLING WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259060 ACCESS SARS-COV-2 IGM IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO CLARE DISCRETE MFG IO 971287 15099590738617

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR