BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12222722 · Received July 24, 2021

    Report

    Report Number
    1221359-2021-02134
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    June 21, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION IT WAS FOUND THAT THIS CASE IS A DUPLICATE OF (B)(4). PLEASE REFER TO MANUFACTURER REPORT NUMBER'S 1221359-2021-02078, 1221359-2021-02079, 1221359-2021-02080 FOR ALL INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO: AWARE DATE ON PREVIOUS MDR(G3). CORRECT AWARE DATE ON PREVIOUS MDR (FOLLOW UP 1) IS 06AUG2021.

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL DENKA COMPANY LIMITED SWAB. REPEAT TESTING WAS PERFORMED GENERATING NEGATIVE RESULTS. PCR CONFIRMATION TESTING WAS PERFORMED AT PUBLIC HEALTH CENTER HOWEVER THE RESULTS WERE NOT PROVIDED. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119631 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown