BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11211974 · Received January 22, 2021

    Report

    Report Number
    1221359-2021-00018
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    November 22, 2020
    Report Date
    January 21, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT PART NUMBER 190-000/ LOT 1004153 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 1004153, TEST BASE PART NUMBER 190-430/ LOT 1004153. 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 RELATED TO KIT LOT 190-000/ LOT 1004153 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION. IT COULD POSSIBILITY BE RELATED TO CROSS CONTAMINATION OR ENVIRONMENTAL CONTAMINATION. DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. ABBOTT TECHNICAL SERVICE FOLLOWED UP WITH THE CUSTOMER AFTER REPLACEMENT INSTRUMENTS WERE SENT. THE CUSTOMER STATED "ALL INSTRUMENTS WERE ABLE TO PASS 2-3 ENVIRONMENTAL SWABS AS NEGATIVE RESULTS" AND CONFIRMED THERE HAVE BEEN NO ADDITIONAL ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNEXPECTED HIGH POSITIVE RESULT RATE FOR ID NOW COVID-19 WHILE PERFORMING ROUTINE PATIENT TESTING. THE CUSTOMER STATED THAT AN INVESTIGATION REVEALED ONE OF THE MACHINES PRODUCED THREE POSITIVE RESULTS IN A ROW WHEN NO SAMPLE/SWAB WAS ADDED TO THE TEST KIT. A SECOND MACHINE APPEARED TO FAIL A CONTROL TEST. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION REGARDING THE SAMPLE TYPE SWAB, REPEAT TESTING, AND CONFIRMATION TESTING WAS NOT PROVIDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. HANDLE SAMPLES ACCORDING TO STANDARD LABORATORY PRACTICES. CLEAN INSTRUMENTS AND SURROUNDING SURFACES ACCORDING TO INSTRUCTIONS PROVIDED IN THE CLEANING SECTION OF THE INSTRUMENT USER MANUAL. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112522 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1004153 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1