BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11683024 · Received April 17, 2021

    Report

    Report Number
    1221359-2021-01174
    Event Type
    Malfunction
    Date Received
    April 17, 2021
    Date of Event
    March 16, 2021
    Report Date
    July 20, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 RECEIVING 2 FALSE POSITIVE RESULTS (SAME PATIENT) ON A DIRECT TESTED NASOPHARYNGEAL FLOQ SWAB WHILE USING THE IDNOW COVID-19 ASSAY ON (B)(6) 2021. CONFIRMATION TESTING THE SAME DAY USING BOTH GENEEXPERT AND COBAS (SEND-OUT SAMPLE) PCR PLATFORMS GENERATED NEGATIVE RESULTS. PER THE CUSTOMER, CONSIDERING THE CLINICAL SYMPTOMS (ASYMPTOMATIC), NEGATIVE WAS THE CORRECT RESULT. THE CUSTOMER REPORTED TREATMENT WAS DELAYED AS A RESULT OF WAITING FOR THE SEND-OUT RESULTS. ADDITIONALLY, PER THE CUSTOMER THE PATIENT EXPERIENCED QUARANTINE ADMISSION TO THE HOSPITAL AND NO FURTHER PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580337 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M140329 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1