BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14774741 · Received June 22, 2022

    Report

    Report Number
    1221359-2022-02971
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 5, 2022
    Report Date
    June 22, 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

    THIS REPORT IS BEING SUBMITTED FOR THE INITIAL AND INVESTIGATION COMPLETETION. 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 CUSTOMER'S ADDRESS EXCEEDS THE TEXT LIMIT: (B)(6). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) INC. ON RETAINED KIT LOT M180378 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 190-000J / LOT M180378 AND TEST BASE PART NUMBER 190-430 / LOT M180378. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR LOT M180378 BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS 0.004%. IN CONCLUSION, THE RETENTION TESTING YIELDED EXPECTED RESULTS WHEN TESTING INTERNAL QC SAMPLES. THE MANUFACTURING BATCH RECORD REVIEW REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE. ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022. REPEAT TESTING WAS PERFORMED ON BOTH (B)(6) GENERATING TWO NEGATIVE RESULTS. NO PATIENT INFORMATION REGARDING TREATMENT OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536577 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M180378 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male