BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    MDR report key: 16506594 · Received March 8, 2023

    Report

    Report Number
    1221359-2023-00473
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    March 3, 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

    ADDITIONAL INFORMATION RECEIVED: H4 - DEVICE MFG DATE AND D4 - EXPIRATION DATE 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 M217001 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: M217001, TEST BASE PART NUMBER 192-430/ LOT: M217001. 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 M217001 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. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    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 REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 ON AN NASOPHARYNGEAL SAMPLE. ON THE SAME DAY PCR CONFIRMATION TESTING WAS PERFORMED TWICE USING PLATFORM: SHIMADZU'S AUTOAMP ON A NASOPHARYNGEAL SAMPLE AND GENERATED TWO NEGATIVE RESULTS RESPECTIVELY. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(4) 2023 ON AN NASOPHARYNGEAL SAMPLE. ON THE SAME DAY PCR CONFIRMATION TESTING WAS PERFORMED TWICE USING PLATFORM: SHIMADZU'S AUTOAMP ON A NASOPHARYNGEAL SAMPLE AND GENERATED TWO NEGATIVE RESULTS RESPECTIVELY. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727406 ID NOW COVID-19 2.0 TEST KIT 24T JAPAN REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M217001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown