BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 16021576 · Received December 21, 2022

    Report

    Report Number
    1221359-2022-05265
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Report Date
    February 8, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M211606 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 M211606 AND TEST BASE PART NUMBER 190-430 / LOT M211606. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION 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. A REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SIMILAR PRODUCT TO 190-000.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE PATIENT RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON AN UNSPECIFIED DATE; AROUND ON (B)(6) 2022. REPEAT TESTING WAS NOT PERFORMED. PCR CONFIRMATION TESTING WAS PERFORMED AT A DIFFERENT HOSPITAL PERFORMED ON (B)(6) 2022 THAT GENERATED A NEGATIVE RESULT. 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
    2053011 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M211606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown