BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11755417 · Received April 30, 2021

    Report

    Report Number
    1221359-2021-01283
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 29, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1023720 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: 1023720, TEST BASE PART NUMBER 190-430 / LOT: 1023720. 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 1023720 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 · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT NASOPHARYNGEAL KITTED SWAB. REPEAT TESTING WAS PERFORMED ON THE SAME DAY WITH A NEW SAMPLE AND ON ANOTHER ID NOW INSTRUMENT AND GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON THE SAME DAY WITH BD ANTIGEN (3 TIMES WITH BD ANTIGEN) AND GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS GETTING TESTED BEFORE GOING TO WORK AT A NURSING HOME. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT OF TREATMENT DUE TO TEST RESULTS. THE CUSTOMER WAS TOLD THAT KIT SWABS ARE NOT APPROVED FOR NASOPHARYNGEAL SAMPLES AND THAT NASOPHARYNGEAL SWABS MUST BE PURCHASED SEPARATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651176 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1023720 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1