BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 13804869 · Received March 18, 2022

    Report

    Report Number
    1221359-2022-01346
    Event Type
    Malfunction
    Date Received
    March 18, 2022
    Date of Event
    February 23, 2022
    Report Date
    March 17, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M167392 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: M167392, TEST BASE PART NUMBER 190-430 / LOT:M167392. 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 M167392 SHOWED THAT THE COMPLAINT RATE IS 0.004%. 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 FOR A PATIENT PERFORMED ON (B)(6) 2022. PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED NEGATIVE RESULTS (PLATFORM: LIAT X2 & BIOFIRE X1). NO ADDITIONAL INFORMATION WAS PROVIDED ON PATIENT IMPACT OR OUTCOME, HOWEVER, THE CUSTOMER CONFIRMED THERE WAS A DELAY OF 2 HOURS IN THE MOVEMENT PATIENT TO APPROPRIATE WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29481 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M167392 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown