BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12022164 · Received June 17, 2021

    Report

    Report Number
    1221359-2021-01789
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    January 24, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1020565 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 1020565 AND TEST BASE PART NUMBER 190-430 / LOT 1020565. 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 1020565 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 SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REFERENCE RELATED MFR. REPORT NUMBERS 1221359-2021-01782, 1221359-2021-01783, 1221359-2021-01784, 1221359-2021-01785, 1221359-2021-01786, 1221359-2021-01787, 1221359-2021-01788, 1221359-2021-01790, 1221359-2021-01791, 1221359-2021-01792, 1221359-2021-01793, 1221359-2021-01794, 1221359-2021-01798, 1221359-2021-01799, 1221359-2021-01800.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEVENTEEN (17) FALSE NEGATIVE RESULTS WHILE USING THE ID NOW COVID-19 ASSAY IN VARIOUS DATES. THIS MFR. REPORT IS EIGHT (8) OF SEVENTEEN (17.) THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021. THE PATIENT TESTED NEGATIVE WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2021 . TESTING WAS PERFORMED PREVIOSLY WITH ID NOW COVID-19 GENERATING POSITIVE RESULTS. THE CUSTOMER THEN TESTED POSITIVE WITH BD MAX ON (B)(6) 2021 . NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911718 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH 1020565

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown