BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13019495 · Received December 16, 2021

    Report

    Report Number
    1221359-2021-03747
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Report Date
    May 5, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT IS BEING UPDATED: A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1048921 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1048921 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: 1048921, TEST BASE PART NUMBER 190-000/ LOT: 1048921. 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 1048921 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOG FILES SUBMITTED TO ABBOTT DIAGNOSTICS SCARBOROUGH WERE DELETED PRIOR TO EXPORT. IN ADDITION: LOT NUMBER 1048921, UDI NUMBER, EXPIRATION DATE AND MANUFACTURER DATE HAS BEEN UPDATED IN THIS REPORT AS ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNSPECIFIED QUANTITY OF UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916917 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1048921

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown