BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14119636 · Received April 15, 2022

    Report

    Report Number
    1221359-2022-01880
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 22, 2022
    Report Date
    May 19, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS . A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORT 1221359-2022-01881.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M174659 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 KIT PART NUMBER 190-000 / LOT M174659 AND TEST BASE PART NUMBER 190-430 / LOT M174659. 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 M174659 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. REFERENCE MFR. REPORTS: 1221359-2022-01880 THROUGH 1221359-2022-01881.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ON (B)(6) 2022 REPEAT TESTING WAS PERFORMED WITH POSITIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION,INCLUDING TREATMENT AND OUTCOME,WAS PROVIDED. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2) TESTS, LOT NUMBER (M174659) QUANTITY (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138265 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M174659 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly