BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 TEST KIT 24T JP

    MDR report key: 15976801 · Received December 14, 2022

    Report

    Report Number
    1221359-2022-10309
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    December 5, 2022
    Report Date
    March 7, 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

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M213667 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 KIT PART NUMBER 190-000J / LOT M213667 AND TEST BASE PART NUMBER 190-430 / LOT M213667. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M213667 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M213667 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : DEVICE DISCARDED; SINGLE-USE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON NASOPHARYNGEAL SAMPLE WITH ANOTHER BRAND SWAB (BRAND NAME UNKNOWN). PER THE CUSTOMER, THE FIRST TEST WAS PERFORMED WITH ID NOW COVID-19 ASSAY GENERATED A POSITIVE RESULT AND THE SECOND TEST CONDUCTED THE SAME DAY WITH ID NOW COVID-19 2.0 ASSAY GENERATED NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON NASOPHARYNGEAL SAMPLE WITH ANOTHER BRAND SWAB (BRAND NAME UNKNOWN). PER THE CUSTOMER, THE FIRST TEST WAS PERFORMED WITH ID NOW COVID-19 ASSAY GENERATED A POSITIVE RESULT AND THE SECOND TEST CONDUCTED THE SAME DAY WITH ID NOW COVID-19 2.0 ASSAY GENERATED NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446599 ID NOW COVID-19 TEST KIT 24T JP REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M213667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown