BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 16373101 · Received February 14, 2023

    Report

    Report Number
    1221359-2023-00310
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    February 7, 2023
    Report Date
    May 11, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    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 193-000 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 NOT RETURNED; SINGLE USE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 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 1095872 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 193-000 / LOT 1095872 AND TEST BASE PART NUMBER 192-430 / LOT 1095872. 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 1095872 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 AND CROSS-CONTAMINATION.A1 (PATIENT IDENTIFIER), B5 (EVENT DESCRIPTION), E1 (COUNTRY), H6 (HEALTH EFFECT - IMPACT CODE), H10 (SIMILAR PRODUCT STATEMENT). H3 OTHER TEXT : OTHER - DEVICE NOT RETURNED; SINGLE USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES PATENT RESULT THREE (3) OF THREE (3). CONFIRMATION PCR TESTING WAS PERFORMED, RESULTS UNKNOWN. ALTHOUGH REQUESTED NO ADDITIONAL, INCLUDING TREATMENT OR OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 . THIS MFR. REPORT ADDRESSES PATIENT THREE (3) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTING VIA UNKNOWN PCR WAS PERFORMED USING AN UNKNOWN SAMPLE TYPE AND GENERATED UNKNOWN RESULTS, AS THE COMPLAINANT DID NOT HAVE ACCESS TO THE RESULTS. THE CUSTOMER NOTED THAT "CERTAIN PATIENT RESULTS ARE CONSIDERED FALSE POSITIVE DUE TO THE CLINICAL PRESENTATION OF PATIENTS". THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964276 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1095872

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown