BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13389263 · Received January 28, 2022

    Report

    Report Number
    1221359-2022-00553
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 4, 2022
    Report Date
    January 28, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1050440 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: 1050440, TEST BASE PART NUMBER 190-430 / LOT: 1050440. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND/OR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1050440 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE FOLLOWING MFR REPORT NUMBERS ARE RELATED TO THIS REPORT: 1221359-2022-00554.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY FOR TWO PATIENTS PERFORMED ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES PATIENT 1 OF 2. THE CUSTOMER REPORTED A POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON THE FIRST TEST ON (B)(6) 2022 USING A NASAL SAMPLE SWAB. REPEAT TESTING WAS DONE IMMEDIATELY AFTER WITH ANOTHER ID NOW MACHINE USING A NASAL SAMPLE SWAB AND THE RESULT WAS NEGATIVE. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752833 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1050440 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown