BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12872945 · Received November 24, 2021

    Report

    Report Number
    1221359-2021-03595
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Report Date
    November 24, 2021
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) ON RETAINED KIT LOT M162489 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 190-000 / LOT M162489. 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 M162489 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 FOR AN UNSPECIFIED NUMBER OF PATIENTS PERFORMED ON AN UNSPECIFIED DATE. CUSTOMER STATES ISSUE HAS BEEN OCCURRING SINCE NEW LOT WAS IMPLEMENTED THE DAY PRIOR. CONFIRMATION TESTING WAS PERFORMED WITH PCR. EXACT RESULTS NOT PROVIDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769993 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR M162489 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown