BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15794709 · Received November 14, 2022

    Report

    Report Number
    1221359-2022-10117
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 31, 2022
    Report Date
    February 1, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M210013 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 190-000 / LOT M210013, TEST BASE PART NUMBER 190-430 / LOT M210013. 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 M210013 SHOWED THAT THE COMPLAINT RATE IS(B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON 31OCT2022.THE PATIENT RECEIVED A POSITIVE RESULT ON ID NOW COVID-19 ON 31OCT2022. THIS MFR. REPORT ADDRESSES TEST NINE (9) OF NINE (9) TESTS. NO CONFIRMATORY TEST WAS PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 9 FALSE POSITIVE RESULTS WITH ID NOW COVID-19 ON (B)(6) 2022. THE PATIENT RECEIVED A POSITIVE RESULT ON ID NOW COVID-19 ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES TEST NINE (9) OF NINE (9) TESTS. NO CONFIRMATORY TEST WAS PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876141 ID NOW COVID-19 TEST KIT 24T (EUA) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M210013 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female