BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 18011395 · Received October 26, 2023

    Report

    Report Number
    1221359-2023-01580
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 10, 2023
    Report Date
    November 13, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4-UDI:(B)(4). 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 M232131 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 193-000/ LOT: M232131, TEST BASE PART NUMBER 192-430/ LOT: M232131. 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 M232131 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 : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    D4-UDI (B)(4). 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. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON NASOPHARYNGEAL SAMPLES ELUTED IN VTM BETWEEN (B)(6) 2023 AND (B)(6) 2023 ON TWO (2) PATIENTS. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 ON A NASOPHARYNGEAL SWAB. INITIAL TESTING WAS PERFORMED WITH THE ID NOW COVID-19 2.0 ASSAY ON (B)(6) 2023 AND GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS PERFORMED AT A MICROBIOLOGY LABORATORY VIA PCR (PLATFORM: GENEXPERT) ON (B)(6) 2023 AND GENERATED A NEGATIVE RESULT. FURTHER TESTING WAS PERFORMED VIA A BIOFIRE FILM ARRAY PANEL AND GENERATE POSITIVE RESULTS FOR CORONAVIRUS NL63. IT IS NOT CLEAR IF BOTH PATIENTS OR ONLY ONE PATIENT WAS TESTED WITH THE BIOFIRE FILM ARRAY PANEL. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON NASOPHARYNGEAL SAMPLES ELUTED IN VTM BETWEEN (B)(6) 2023 AND (B)(6) 2023 ON TWO (2) PATIENTS. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 ON A NASOPHARYNGEAL SWAB. INITIAL TESTING WAS PERFORMED WITH THE ID NOW COVID-19 2.0 ASSAY ON (B)(6) 2023 AND GENERATED A POSITIVE RESULT. CONFIRMATION TESTING WAS PERFORMED AT A MICROBIOLOGY LABORATORY VIA PCR (PLATFORM: GENEXPERT) ON (B)(6) 2023 AND GENERATED A NEGATIVE RESULT. FURTHER TESTING WAS PERFORMED VIA A BIOFIRE FILM ARRAY PANEL AND GENERATE POSITIVE RESULTS FOR CORONAVIRUS NL63. IT IS NOT CLEAR IF BOTH PATIENTS OR ONLY ONE PATIENT WAS TESTED WITH THE BIOFIRE FILM ARRAY PANEL. 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
    2140982 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M232131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown