BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14225021 · Received April 27, 2022

    Report

    Report Number
    1221359-2022-02275
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    March 30, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.REFERENCE MFR. REPORTS: 1221359-2022-02276

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: G3, G4, G6, H2, AND H6. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1062475 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 KIT PART NUMBER 190-000 / LOT 1062475 AND TEST BASE PART NUMBER 190-430 / LOT 1062475. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS WITH NO FALSE NEGATIVE RESULTS OBSERVED. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1062475 SHOWED THAT THE COMPLAINT RATE IS 0.002%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE AN ASSIGNABLE ROOT CAUSE, AS THE LOG FILES WERE NOT PROVIDED FOR INVESTIGATION; HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS CONSIDERED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 ASSAY PERFORMED ON VARIOUS DATES. THIS REPORT IS ONE (1) OF TWO (2). THE CUSTOMER REPORTED ONE FALSE POSITIVE WITH THE IDNOW COVID-19 ASSAY PERFORMED ON A NASAL SWAB SAMPLE (COLLECTION DATE: (B)(6) 2022). CONFIRMATION TESTING (PLATFORM: CORE) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6) 2022 IN VIRAL TRANSPORT MEDIUM GENERATED A NEGATIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970737 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1062475 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown