BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11682652 · Received April 16, 2021

    Report

    Report Number
    1221359-2021-01027
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 15, 2021
    Report Date
    July 12, 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

    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 PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL UNSPECIFIED SWAB. REPEAT TESTING USING A NEW SAMPLE THE SAME DAY GENERATED NEGATIVE RESULTS. CONFIRMATORY TESTING ON A NASOPHARYNGEAL UNSPECIFIED SWAB USING PANBIO COVID-19 AG RAPID TEST AND REAL-TIME PCR ON THE SAME DAY ALSO GENERATED NEGATIVE RESULTS. PER THE CUSTOMER NO DEATH OR SERIOUS INJURY OCCURRED, THE PATIENT'S HOSPITALIZATION WAS DELAYED (TRANSFER TO THE RECEIVING FACILITY UNTIL THE RESULTS OF THE OUTSOURCES TEST). HOWEVER, THERE WAS NO IMPACT TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579371 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