BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    MDR report key: 16594871 · Received March 22, 2023

    Report

    Report Number
    1221359-2023-00537
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    March 16, 2023
    Report Date
    May 24, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    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 M218779 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 192-000J / LOT M218779 AND TEST BASE PART NUMBER 192-430 / LOT M218779. 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 M218779 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH ID NOW COVID-19 2.0 ON (B)(6) 2023. PER CUSTOMER, THE PATIENT RECEIVED POSITIVE RESULT WITH ID NOW COVID-19 2.0. A CONFIRMATORY TEST PCR (GENEXPERT, BECKMAN COULTER) WAS PERFORMED ON NASOPHARYNGEAL SWAB, AND GENERATED A NEGATIVE RESULT. SAMPLE FOR PCR COLLECTED AFTER 15 MIN OF ID NOW SAMPLE COLLECTION. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS ASYMPTOMATIC. ALSO, THE CUSTOMER STATED THAT THE PATIENT HAD COVID IN (B)(6) 2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH ID NOW COVID-19 2.0 ON (B)(6) 2023. PER CUSTOMER, THE PATIENT RECEIVED POSITIVE RESULT WITH ID NOW COVID-19 2.0. A CONFIRMATORY TEST PCR (GENEXPERT, BECKMAN COULTER) WAS PERFORMED ON NASOPHARYNGEAL SWAB, AND GENERATED A NEGATIVE RESULT. SAMPLE FOR PCR COLLECTED AFTER 15 MIN OF ID NOW SAMPLE COLLECTION. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS ASYMPTOMATIC. ALSO, THE CUSTOMER STATED THAT THE PATIENT HAD COVID IN (B)(6) 2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103564 ID NOW COVID-19 2.0 TEST KIT 24T JAPAN REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M218779

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown