BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15419820 · Received September 14, 2022

    Report

    Report Number
    1221359-2022-02492
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Report Date
    December 29, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M212794 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 M212794, TEST BASE PART NUMBER 190-430 / LOT M212794. 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 M212794 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE .HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED. REFERENCE MFR. REPORTS: 1221359-2022-02490 THROUGH 1221359-2022-02492.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS . A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-02490 THROUGH 1221359-2022-02492. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA : H10 (LOT NUMBER,M211336). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M211336 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 M211336, TEST BASE PART NUMBER 190-430 / LOT M211336. 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 M211336 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 ASSAY PERFORMED ON VARIOUS DATES INVOLVING VARIOUS LOTS . THIS REPORT IS THREE (3) OF THREE (3) AND ADDRESSES LOT M211336 TOTAL QUANTITY (1) WAS PERFORMED ON (B)(6) 2022. THE CUSTOMER RECEIVED POSITIVE RESULT ON (B)(6) 2022. A CONFIRMATION TEST (PCR) WAS PERFORMED AND GENERATED A NEGATIVE RESULT . NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673213 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M211336 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown