BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 18076511 · Received November 6, 2023

    Report

    Report Number
    1221359-2023-01626
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 2, 2023
    Report Date
    December 6, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    D4-(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. THREE FALSE POSITIVE RESULTS WERE OBTAINED DURING QUALITY CONTROL RELEASE TESTING WHICH IS ACCEPTABLE ACCORDING TO RELEASE SPECIFICATIONS. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M233909 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: M233909, TEST BASE PART NUMBER 192-430/ LOT: M233909. 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 M233909 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ELEVEN (11) FALSE POSITIVE RESULTS AND ONE (1) FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON THREE (3) DIFFERENT LOTS BETWEEN (B)(6) 2023 ON TWELVE (12) PATIENTS. THIS MFR. REPORT ADDRESSES LOT M233909 (TOTAL QUANTITY: 5) AND PATIENT SEVEN (7) OF TWELVE (12). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. CONFIRMATION TESTING VIA PCR (PLATFORM: PANTHER) WAS PERFORMED ON (B)(6) 2023 AND GENERATED A NEGATIVE RESULT ON AN UNKNOWN SAMPLE TYPE ELUTED IN VTM. REPEAT TESTING WAS NOT PERFORMED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ELEVEN (11) FALSE POSITIVE RESULTS AND ONE (1) FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON THREE (3) DIFFERENT LOTS BETWEEN (B)(6) 2023 AND (B)(6) 2023 ON TWELVE (12) PATIENTS. THIS MFR. REPORT ADDRESSES LOT M233909 (TOTAL QUANTITY: 5) AND PATIENT SEVEN (7) OF TWELVE (12). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. CONFIRMATION TESTING VIA PCR (PLATFORM: PANTHER) WAS PERFORMED ON (B)(6) 2023 AND GENERATED A NEGATIVE RESULT ON AN UNKNOWN SAMPLE TYPE ELUTED IN VTM. REPEAT TESTING WAS NOT PERFORMED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146868 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M233909

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown