BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15638643 · Received October 20, 2022

    Report

    Report Number
    1221359-2022-04506
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 12, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 190-000J, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE ALL RELATED MFR. REPORT NUMBERS: 1221359-2022-04505 THROUGH 1221359-2022-04506.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M213568 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 M213568 AND TEST BASE PART NUMBER 190-430 / LOT M213568. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M213568 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 SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 2 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON AN UNKNOWN DATE 2-3 WEEKS AGO AND (B)(6) 2022 USING LOT NUMBERS M213568. THIS REPORT ADDRESSES PATIENT RESULTS 2 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 THAT GENERATED A POSITIVE RESULT. A PCR TEST (UNKNOWN PLATFORM) WAS PERFORMED ON THE SAME DAY AND GENERATED NEGATIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002700 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M213568 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown