BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    MDR report key: 22700003 · Received August 4, 2025

    Report

    Report Number
    1221359-2025-00329
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHONE NUMBER PROVIDED BY THE CUSTOMER WAS (B)(6). THIS NUMBER WAS ONE-DIGIT TOO LONG FOR E1- PHONE NUMBER. 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 REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THE PHONE NUMBER PROVIDED BY THE CUSTOMER WAS (B)(6). THIS NUMBER WAS ONE-DIGIT TOO LONG FOR E1- PHONE NUMBER. 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. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M834782 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: M834782, TEST BASE PART NUMBER 192-430 / LOT: M834782. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND/OR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M834782 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, IT COULD HAVE POSSIBLY BEEN RELATED TO SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE COULD HAVE INTERFERED WITH TEST RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2025. THE CUSTOMER INDICATED THAT AN HOUR LATER AT A DIFFERENT HOSPITAL, THE PATIENT TESTED POSITIVE WITH AN ANTIGEN TEST (BRAND UNKNOWN) USING AN UNKNOWN SAMPLE TYPE. THE CUSTOMER STATED THAT THE PATIENT WAS SYMPTOMATIC (FEVER). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2025. THE CUSTOMER INDICATED THAT AN HOUR LATER AT A DIFFERENT HOSPITAL, THE PATIENT TESTED POSITIVE WITH AN ANTIGEN TEST (BRAND UNKNOWN) USING AN UNKNOWN SAMPLE TYPE. THE CUSTOMER STATED THAT THE PATIENT WAS SYMPTOMATIC (FEVER). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585055 ID NOW COVID-19 2.0 TEST KIT 24T JAPAN REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M834782 04571226475447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown