BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15477305 · Received September 24, 2022

    Report

    Report Number
    1221359-2022-04783
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Report Date
    October 19, 2022
    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

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M211013 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 TEST KIT PART NUMBER 190-000 / LOT M211013 AND TEST BASE PART NUMBER 190-430 / LOT M211013 QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M211013 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS LOGFILES WERE NOT RETURNED FOR ANALYSIS

    Additional Manufacturer Narrative · 0

    PMA/510K: SIMILAR PRODUCT TO 190-000. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR.REPORT NUMBERS: 1221359-2022-04782.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE TEST RESULTS WITH THE ID NOW COVID-19 ASSAY FOR TWO PATIENTS PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES PATIENT TWO(2) OF TWO (2). CONFIRMATION TESTING WAS PERFORMED ON UNKNOWN SWAB VIA AN UNKNOWN PCR PLATFORM PERFORMED ON THE SAME DATE GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123968 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M211013 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown