BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGM

    MDR report key: 11716383 · Received April 23, 2021

    Report

    Report Number
    9680746-2021-00032
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 23, 2021
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKO
    UDI-DI
    15099590738617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGM REAGENT WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF OTHER INSTRUMENT ISSUES. THERE WERE NO REPORTS OF OTHER ISSUES WITH THIS ASSAY. THE PRIMARY CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST AN INSTRUMENT MALFUNCTION. PER CURRENT CDC (UNITED STATES CENTERS FOR DISEASE CONTROL AND PREVENTION) GUIDELINES AVAILABLE ON THE CDC WEBSITE, IGM ANTIBODY CAN PERSIST FOR WEEKS TO MONTHS FOLLOWING INFECTION. PERSISTENCE OF DETECTABLE ANTIBODIES MAY VARY BY THE TEST USED.

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED PERSISTENT ELEVATED SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971256) RESULTS WERE GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (PART NUMBER A71456 AND SERIAL NUMBER (B)(4)). THE PHYSICIAN REPORTED THAT ONE PATIENT THAT PERSISTENT ELEVATED SARS-COV-2 IGM RESULTS POST COVID-19 INFECTION WHILE THE PATIENT¿S SPOUSE¿S SARS-COV-2 IGM RESULTS HAD RETURNED TO ZERO WEEKS PRIOR. THE DATA SUPPLIED BY THE PHYSICIAN ALSO INCLUDED SARS-COV-2 IGG RESULTS: (B)(6). NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. CALIBRATION, QC, AND SYSTEM CHECK DATA WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT BELIEVE THE IGM VALUES OBTAINED ON THE INSTRUMENT TO BE INCORRECT. THE INQUIRY WAS REGARDING THE NORMAL TIME OF IGM REACTIVITY IN INDIVIDUALS. THERE WERE NO REPORTS OF OTHER INSTRUMENT ISSUES. THERE WERE NO REPORTS OF OTHER ISSUES WITH THIS ASSAY. 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
    608833 ACCESS SARS-COV-2 IGM IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO CLARE DISCRETE MFG IO 971256 15099590738617

    Patients

    Seq Age Sex Outcome Treatment
    1