BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14456646 · Received May 20, 2022

    Report

    Report Number
    1221359-2022-02697
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    March 12, 2022
    Report Date
    June 20, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SIMILAR PRODUCT TO 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SEE RELATED MFR. REPORT NUMBERS FOR UNCONFIRMED FALSE POSITIVE RESULTS:1221359-2022-02709. SEE RELATED MFR. REPORT NUMBERS FOR PATIENTS WHICH HAD CONFIRMATORY PCR TESTING: 1221359-2022-02233 THROUGH 1221359-2022-02240.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4: LOT NUMBER, EXPIRATION DATE, UDI # H4: DEVICE MANUFACTURE DATE INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1063017 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 191-000 / LOT 1063017 AND TEST BASE PART NUMBER 190-430 / LOT 1063017. 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 1063017 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE AN ASSIGNABLE ROOT CAUSE AS THE LOGFILES WERE NOT PROVIDED FOR INVESTIGATION, HOWEVER SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THIRTEEN UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON KITTED NASAL SWAB SAMPLES ON (B)(6) 2022. THIS REPORT IS FOR PATIENT ONE (1) OF THIRTEEN (13). THE CUSTOMER INDICATED THAT NO REPEAT OR CONFIRMATION TESTING WAS PERFORMED FOR THIS PATIENT AND BELIEVES THAT THIS WAS A FALSE POSITIVE RESULT AS THEY WERE RECEIVING MANY FALSE POSITIVE RESULTS WHICH HAD BEEN CONFIRMED AS FALSE POSITIVE WITH PCR TESTING. NO ADDITIONAL INFORMATION WAS REPORTED REGARDING PATIENT HEALTH STATUS AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564154 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1063017 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown