BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12081730 · Received June 28, 2021

    Report

    Report Number
    1221359-2021-01843
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1025736 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 191-000/ LOT: 1025736, TEST BASE PART NUMBER 190-430/ LOT: 1025736. 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 1025736 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED, HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    ESTABLISHMENT PHONE NUMBER: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY ON A DIRECT TESTED THROAT AND NASOPHARYNGEAL SWABS PERFORMED ON (B)(6) 2021. REPEATING TESTING WAS NOT PERFORMED. PCR CONFIRMATION TESTING (AG : ABBOTT) GENERATED NEGATIVE RESULTS AND ( AB: NO ABBOTT) GENERATED POSITIVE RESULTS PERFORMED ON A THROAT AND NASOPHARYNGEAL SWABS ON (B)(6) 2021. THE CUSTOMER STATED THE PATIENT WAS VACCINATED WITH PFIZER IN (B)(6), THE TEST WAS MANDATORY FOR THE PATIENT TO GET BACK HOME. THE PATIENT HAD ARRIVED IN (B)(6) WITH A NEGATIVE PCR. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977080 ID NOW COVID-19 ASSAY IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1025736 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1