BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    MDR report key: 16437439 · Received February 24, 2023

    Report

    Report Number
    1221359-2023-00392
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 1, 2023
    Report Date
    May 16, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    00811877011354
    PMA / PMN Number
    EUA210517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE PROVIDED IN B3 IS AN ESTIMATE AS THE EXACT DATE OF OCCURRENCE WAS NOT PROVIDED. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1092567 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 192-000/ LOT: 1092567, TEST BASE PART NUMBER 192-430/ LOT: 1092567. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS INVALID PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1092567 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

    THE EVENT DATE PROVIDED IS AN ESTIMATE AS THE EXACT DATE OF OCCURRENCE WAS NOT PROVIDED. 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 AN UNKNOWN NUMBER OF INVALID RESULTS WITH THE ID NOW COVID-19 2.0 PERFORMED ON AN UNKNOWN DATE. REPEAT TESTING WAS PERFORMED ON AN UNKNOWN DATE GENERATING INVALID RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED A DELAY IN SURGERY DUE TO THE TEST RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING THE TYPE OF SURGERY THAT WAS DELAYED, TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF INVALID RESULTS WITH THE ID NOW COVID-19 2.0 PERFORMED ON AN UNKNOWN DATE. REPEAT TESTING WAS PERFORMED ON AN UNKNOWN DATE GENERATING INVALID RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED A DELAY IN SURGERY DUE TO THE TEST RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION INCLUDING THE TYPE OF SURGERY THAT WAS DELAYED, TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059251 ID NOW COVID-19 2.0 TEST KIT 24T (EUA) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1092567 00811877011354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown