BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15164856 · Received August 4, 2022

    Report

    Report Number
    1221359-2022-04261
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 24, 2022
    Report Date
    August 16, 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
    ND, US
    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

    ADDITIONAL INFORMATION: D4: EXPIRATION DATE. H4: MFG DATE. INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1061296 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 1061296 AND TEST BASE PART NUMBER 190-430 / LOT 1061296. 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 1061296 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 PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022 ON A DIRECT TESTED, KITTED, NASAL SWAB SAMPLE. THE PATIENT PRESENTED AT THE EMERGENCY ROOM (ER) WITH COVID-19 SYMPTOMS AND DIFFICULTY BREATHING WHERE THEY WERE TREATED WITH OXYGEN. THE PATIENT WAS TRANSFERRED TO A LOCAL HOSPITAL VIA AMBULANCE AND WHILE ON THE WAY TO THE HOSPITAL THEY WERE INTUBATED DUE TO THE BREATHING DIFFICULTIES. THE PATIENT WAS TESTED AGAIN FOR COVID-19 (PLATFORM UNKNOWN) AT THE HOSPITAL THAT THEY WERE TRANSFERRED TO WHICH GENERATED A POSITIVE RESULT. DUE TO THE PATIENT BEING TRANSFERRED TO A DIFFERENT LOCATION, THE CUSTOMER HAS NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322357 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1061296 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female