BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15522361 · Received October 1, 2022

    Report

    Report Number
    1221359-2022-04567
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    September 10, 2022
    Report Date
    September 30, 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

    TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS (B)(4) INC. ON RETAINED KIT LOT 1086021 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 1086021 AND TEST BASE PART NUMBER 190-430 / LOT 1086021. 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 1086021 SHOWED THAT THE COMPLAINT RATE IS 0.002%. ABBOTT DIAGNOSTICS (B)(4) INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. REFERENCE MFR. REPORTS: 1221359-2022-04559.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NINE FALSE NEGATIVES RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON VARIOUS DATES INVOLVING VARIOUS LOTS. THIS REPORT IS NINE (9) OF NINE (9) AND ADDRESSES LOT 1086021 (TOTAL QUANTITY 1). THE CUSTOMER REPORTED ONE FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON A NASAL SWAB SAMPLE (COLLECTION DATE: (B)(6) 2022. CONFIRMATION TESTING (PLATFORM: DIASORIN) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6) 2022 IN VIRAL TRANSPORT MEDIA GENERATED A POSITIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479273 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1086021 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown