BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13361659 · Received January 26, 2022

    Report

    Report Number
    1221359-2022-00564
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    December 23, 2021
    Report Date
    January 26, 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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M173009 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: M173009, TEST BASE PART NUMBER 190-000/ LOT: M173009. 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 M173009 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE LOGFILE WAS NOT RETURNED FOR ANALYSIS INTO THE ROOT CAUSE OF THE FALSE POSITIVE RESULTS. RELATED REPORTS: 1221359-2022-00563, 1221359-2022-00565, 1221359-2022-00566.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR FALSE POSITIVE RESULTS DURING ROUTINE TESTING FOR THREE STAFF MEMBERS, WITH THE ID NOW COVID-19 ASSAY, USING NASAL SWAB SAMPLES. THE FIRST ROUTINE ID NOW COVID-19 ASSAY WAS PERFORMED ON (B)(6) 2021 AT 6:33PM, WHICH GENERATED A POSITIVE RESULT. THE SECOND ROUTINE ID NOW COVID-19 ASSAY WAS PERFORMED ON (B)(6) 2021 AT 3:57PM WHICH GENERATED A POSITIVE RESULT. THE THIRD ID NOW COVID-19 ASSAY WAS PERFORMED ON (B)(6) 2021 AT 1:29PM, WITH REPEAT TESTING AT 1:38PM AND BOTH TESTS GENERATED POSITIVE RESULTS. CONFIRMATION PCR TESTING WAS PERFORMED ON AN UNKNOWN DATE FOR ALL THREE STAFF MEMBERS IN WHICH THE RESULTS WERE NEGATIVE. THE SAMPLE TYPE USED FOR THE CONFIRMATION PCR TESTING WAS NOT PROVIDED. THE CUSTOMER STATED THAT ALL THREE STAFF MEMBERS WERE ASYMPTOMATIC. NO ADVERSE HEALTH OUTCOMES WERE REPORTED DUE TO THE TEST RESULTS. THIS MANUFACTURER REPORT ADDRESSES FALSE POSITIVE RESULT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114859 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M173009 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown