BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11705752 · Received April 22, 2021

    Report

    Report Number
    1221359-2021-01185
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Report Date
    July 23, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. AFTER FURTHER INVESTIGATION IT WAS IDENTIFIED TWO LOT #S ARE RELATED TO THIS EVENT. THIS IS NOW MFR. REPORT ONE (1) OF TWO (2). REFERENCE MFR. REPORT: 1221359-2021-01579.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M141938 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: M141938, TEST BASE PART NUMBER 190-430 / LOT: M141938. 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 M141938 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. ESTABLISHMENT NAME: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 11 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ASSAY. THIS TOOK PLACE IN (B)(6) 2021. CONFIRMATION TESTING WAS PERFORMED WITH RT-PCR AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THAT 7 OF THE CASES PREVIOUSLY HAD COVID-19. DATES RANGING BETWEEN (B)(6) 2020 AND (B)(6) 2020. ADDITIONALLY, THESE PATIENTS HAVE COMPLETED THEIR VACCINATIONS IN (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605956 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M141938

    Patients

    Seq Age Sex Outcome Treatment
    1