BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11742525 · Received April 28, 2021

    Report

    Report Number
    1221359-2021-01274
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 29, 2021
    Report Date
    September 14, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1017887 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 191-000 / LOT M140860. TEST BASE PART NUMBER 190-430 / LOT M140860. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS.ALL TESTS WERE VALID AND PERFORMED AS EXPECTED WITH NO FALSE POSITIVE RESULTS REPLICATED. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M140860 SHOWED THAT THE COMPLAINT RATE IS 0.004%. IN ADDITION, A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M140860 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NIPRO SPONGE NASOPHARYNGEAL SWAB. REPEAT TESTING WAS PERFORMED TWICE ON (B)(6) 2021 AND ONCE ON (B)(6) 2021 USING A NEW SAMPLE (NASOPHARYNGEAL) WITH THE ID NOW COVID-19 ASSAY AND GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO TREATMENT WAS PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY BASED ON THE POSITIVE RESULT OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632746 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M140860 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R