BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12173693 · Received July 15, 2021

    Report

    Report Number
    1221359-2021-01918
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Report Date
    November 15, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M142049 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: M142049 , TEST BASE PART NUMBER 190-430 / LOT: M142049 . 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 M142049 SHOWED THAT THE COMPLAINT RATE IS 0.007%. 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

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT ON A NASAL SWAB WITH ID NOW COVID-19 ASSAY. REPEAT TESTING WAS PERFORMED AND GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 WITH PCR AND GENERATED NEGATIVE RESULTS. PER THE CUSTOMER, THERE WAS NO PATIENT HARM DUE TO TEST RESULTS. ADDITIONALLY, THERE WAS NO DELAY OR IMPACT IN TREATMENT DUE TO TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072418 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M142049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening