BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12317149 · Received August 13, 2021

    Report

    Report Number
    1221359-2021-02255
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Report Date
    March 11, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    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

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

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PERIOD BETWEEN 21MAR2021 TO 01JUN2021, 325 TEST WERE PERFORMED WITH THE ID NOW COVID-19 ASSAY, AND 36 OF THOSE GENERATED INVALID RESULTS (11.1% OF INVALID TESTS). THE CUSTOMER REPORTED THAT THE ID NOW COVID-19 ASSAYS WERE PERFORMED (B)(6) 2021 USING A DIRECT TESTED NIPRO SPONGE TYPE R NASOPHARYNGEAL SWABS. REPEAT AND CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED A DELAY IN TREATMENT DUE TO THE TEST RESULTS. ALTHOUGH REQUESTED, THE SPECIFICS REGARDING THE PATIENT'S DELAY AND IMPACT OF TREAT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216705 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M144031 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown