BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11682147 · Received April 16, 2021

    Report

    Report Number
    1221359-2021-01024
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 11, 2021
    Report Date
    July 16, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M140329 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 M140329, TEST BASE PART NUMBER 190-430 / LOT M140329. 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 M140329 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2021 USING A DIRECT TESTED NASOPHARYNGEAL SWAB (FLOQ TYPE SWAB). REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION PCR TESTING (BECKMAN'S GENEXPERT ) ON AN UNCONFIRMED DATE ON A NASOPHARYNGEAL SAMPLE GENERATED NEGATIVE RESULTS. PER THE CUSTOMER, THE PATIENT WAS TRANSPORTED TO THE FACILITY WITH A FRACTURE OF THE TROCHANTERIC REGION OF THE RIGHT FEMUR (NO SYMPTOMS SUCH AS COUGHING BUT WITH FEVER AT 37.6 ° C), AND A CONFIRMATION TEST WAS PERFORMED JUST IN CASE BEFORE TREATMENT, AND THE RESULT WAS POSITIVE FOR ID NOW COVID-19. AFTER THAT, THE PATIENT WAS TRANSFERRED TO THE NEARBY (B)(6) CENTRAL HOSPITAL, AND THE NEW SAMPLE WAS COLLECTED AND PERFORMED A CONFIRMATORY TEST USING BECKMAN'S GENEXPERT (PCR) AND THE RESULT WAS NEGATIVE. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE FALSE RESULT AND THERE WAS NO DELAY OR IMPACT TO THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579343 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M140329

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR