BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15015452 · Received July 14, 2022

    Report

    Report Number
    1221359-2022-03606
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    July 3, 2022
    Report Date
    July 26, 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 FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 190-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORT: 1221359-2022-03607.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M200048 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 M200048 AND TEST BASE PART NUMBER 190-430/ LOT M200048. 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 M200048 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR TWO PATIENTS PERFORMED ON TWO DATES WITH ONE LOT. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASOPHARYNGEAL SAMPLE WITH A NIPRO SPONGE SWAB TYPE R. CONFIRMATION TESTING WITH THE SMART GENE PCR GENERATED A NEGATIVE RESULT (CT VALUES NOT PROVIDED). 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
    469356 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M200048 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male