BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 15136706 · Received July 30, 2022

    Report

    Report Number
    1221359-2022-04243
    Event Type
    Malfunction
    Date Received
    July 30, 2022
    Date of Event
    July 27, 2022
    Report Date
    August 9, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT LOT 1063203 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 1063203, TEST BASE PART NUMBER 190-430 / LOT 1063203. 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 1063203 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON A PATIENT IN THE MONTH OF JUL2022. REPEAT TESTING WAS GENERATED A NEGATIVE RESULT, PCR CONFIRMATION TESTING WAS PERFORMED ON A NEW SAMPLE WITH IN 5 MINUTES AND GENERATED NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON A PATIENT ON (B)(6) 2022 DIRECT TESTED ON A NASOPHARYNGEAL SAMPLE. 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 BUT THEY HAD TO QUARANTINE UNTIL PCR RESULTS ARE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553800 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1063203 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male