BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14401102 · Received May 13, 2022

    Report

    Report Number
    1221359-2022-02406
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 20, 2022
    Report Date
    June 9, 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

    ATTEMPTS ARE BEING MADE TO OBTAIN CLARIFICATION REGARDING HOW THE RESULTS WERE DISCREPANT. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1062684 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 1062684 AND TEST BASE PART NUMBER 190-430 / LOT 1062684. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1062684 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1062684 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE DISCREPANT RESULTS WITH THE ID NOW COVID-19 ASSAY ON DIRECT TESTED NASAL KITTED SWAB SAMPLES ON VARIOUS DAYS FROM THREE SEPARATE PATIENTS. THIS REPORT IF FOR PATIENT ONE OF THREE. THE PATIENT INITIALLY TESTED POSITIVE WITH THE ID NOW COVID-19 ASSAY ON UNKNOWN DATE. THE CUSTOMER REPORTED THAT THE PATIENT HAD A SECOND TEST WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022 WHICH GENERATED DISCREPANT RESULTS. THE CUSTOMER REPORTED THAT CONFIRMATORY TESTING HAD NOT BEEN PERFORMED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION REGARDING PATIENT HEALTH STATUS OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039874 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1062684 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female