BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15690599 · Received October 28, 2022

    Report

    Report Number
    1221359-2022-05194
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    October 21, 2022
    Report Date
    February 1, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE SECOND LOT ON THE INITIAL REPORT IN H10, M213659, WAS REPORTED IN ERROR AND WAS FOUND THAT THE RESULT SHOULD NOT HAVE BEEN CONSIDERED DUE TO THE SAME SAMPLE HAVING BEEN USED. INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M213618 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 190-000J / LOT M213618 AND TEST BASE PART NUMBER 190-430 / LOT M213618. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS CONFLICTING PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M213618 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.

    Additional Manufacturer Narrative · 0

    LOT NUMBER 1: M213618, LOT NUMBER 2: M213659. SIMILAR PRODUCT TO 190-000. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 USING TWO DIFFERENT LOT NUMBERS. THE CUSTOMER TESTED NEGATIVE WITH THE ID NOW COVID-19 ASSAY WITH A DIRECT TESTED KIT SWAB ON A NASOPHARYNGEAL SAMPLE. A FEW MINUTES LATER REPEAT TESTING WAS PERFORMED WITH THE SAME SWAB ON A DIFFERENT ID NOW INSTRUMENT AND GENERATED A POSITIVE RESULT. THE PATIENT WAS REPORTEDLY SYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2868153 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M213618 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown