BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12781461 · Received November 9, 2021

    Report

    Report Number
    1221359-2021-03460
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 16, 2021
    Report Date
    December 7, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475027
    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

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M162489 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000J / LOT: M162489, TEST BASE PART NUMBER 190-430 / LOT: M162489. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M162489 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR. REPORT: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) UNCONFIRMED FALSE POSITIVE RESULTS PERFORMED ON MULTIPLE DATES. THIS MFR. REPORT ADDRESSES ONE (1) UNCONFIRMED FALSE POSITIVE RESULT PERFORMED ON (B)(6) 2021. THIS IS REPORT TWO (2) OF TWO (2). THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT ON A DIRECTLY TESTED NASOPHARYNGEAL NIPRO SPONGE SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6)2021. REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 AND GENERATED POSITIVE RESULTS. PCR TESTING WAS NOT PERFORMED. PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC WITH A FEVER. ADDITIONALLY, THERE WAS NO PATIENT HARM DUE TO THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678526 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M162489 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization