BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11699363 · Received April 21, 2021

    Report

    Report Number
    1221359-2021-01181
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 24, 2021
    Report Date
    July 29, 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 · 0

    H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M140860 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: M140860 , TEST BASE PART NUMBER 190-430 / LOT: M140860 . 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 M140860 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL NIPRO SPONGE SWAB TYPE S AND FLOQ SWABS. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 AND GENERATED NEGATIVE RESULTS. ANOTHER CONFIRMATION TEST WAS PERFORMED ON (B)(6) 2021 WITH TAKARA BIO RT-PCR, THIS TEST WAS SENT OUT FOR RESULTS. THE TEST GENERATED NEGATIVE RESULTS. ONE MORE CONFIRMATION TEST WAS PERFORMED ON (B)(6) 2021, GENE XPERT PCR TEST GENERATED NEGATIVE RESULTS. REPEAT TESTING ON THE ID NOW COVID-19 ASSAY WITH A NEW SAMPLE AND WAS PERFORMED ON (B)(6) 2021 AND GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS DELAYS AND IMPACT OF TREATMENT DUE TO TEST RESULTS. THERE WERE DELAYS UNTIL THE RESULTS WERE JUDGED AS A FALSE POSITIVE. THE PATIENTS SURGERY WENT ON AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597476 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M140860

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR