BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14240491 · Received April 28, 2022

    Report

    Report Number
    1221359-2022-02172
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M179999 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 191-000 / LOT M179999 AND TEST BASE PART NUMBER 190-430 / LOT M179999. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M179999 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M179999 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CONFLICTING RESULT, WITH THE ID NOW COVID 19 WAS PERFORMED ON (B)(6) 2022 NASOPHARYNGEAL SWAB. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC. CONFORMATION TEST ( PANBIO PANBIO-19 AG RAPID TEST DEVICE AND COVID-19 NEOKIT-TECNOAMI) WAS PERFORMED ON (B)(6) 2022 NASOPHARYNGEAL SWAB,AND GENERATED NOT DETECTABLE RESULT. THE CUSTOMER STATED THERE WAS A DELAY IN TREATMENT,DRAINAGE OF THE PATIENT SEPTIC ARTHRITIS WAS DELAYED. THE CUSTOMER STATED THAT THE PATIENT RECEIVED SURGICAL DRAINAGE AND ANTIBIOTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97949 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M179999 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female