BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12590041 · Received October 7, 2021

    Report

    Report Number
    1221359-2021-03072
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 16, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1032022 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 191-000/LOT 1032022, TEST BASE PART NUMBER 190-430/LOT 1032022. 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 1032022 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED. REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND HAVE NOT IDENTIFIED A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2021. FOUR POSITIVE RESULTS WERE REPORTED BACK TO BACK. CUSTOMER SUSPECTS THESE TO BE FALSE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. CUSTOMER RAN A NEW PATIENT SAMPLE AFTER CLEANING THE INSTRUMENT. THIS RESULT WAS NEGATIVE. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. 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
    1485927 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1032022 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown