BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12011073 · Received June 16, 2021

    Report

    Report Number
    1221359-2021-01770
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 17, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION : B5: CUSTOMER REPORTED TWO(2) FALSE POSITIVE RESULTS ON THE ID NOW COVID-19 ASSAY. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1021992 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 190-000 / LOT: 1021992, TEST BASE PART NUMBER 130-430 / LOT: 1021992 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 1021992 SHOWED THAT THE COMPLAINT RATE IS 0.006%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    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 A FALSE POSITIVE RESULTS ON THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT NASOPHARYNGEAL SWAB. REPEATING TESTING WAS NOT PERFORMED. PCR CONFIRMATION TESTING ON A NASOPHARYNGEAL SWAB ( ON THE SAME DAY) GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. 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
    907874 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1021992 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1