BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11284947 · Received February 5, 2021

    Report

    Report Number
    1221359-2021-00260
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 9, 2021
    Report Date
    March 5, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO SPECIFIC PATIENT SAMPLE, CROSS CONTAMINATION, OR ENVIRONMENTAL CONTAMINATION. BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN THE PACKAGE INSERT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE INVESTIGATION IS STILL IN PROGRESS, TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1013088 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000/ LOT 1013088 AND TEST BASE PART NUMBER 190-430/ LOT 1013088 WERE REVIEWED. THIS 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 1013088 SHOW THAT THE COMPLAINT RATE IS (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER COMPLETION. PLEASE SEE RELATED MFR REPORT #S:1221359-2021-00233, 1221359-2021-00234 AND 1221359-2021-00236.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A DIRECT KITTED NASAL SWAB OF BOTH NOSTRILS WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021. CONFIRMATION TESTING FROM SAMPLE COLLECTED ON THE SAME DAY WITH ALINITY M2000 GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA. PER THE ID NOW COVID-19 PRODUCT INSERT, PRECAUTIONS INCLUDE: 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. REFER TO SECTION 1.6, MAINTENANCE & CLEANING, FOR FURTHER INFORMATION. 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
    181993 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH INC. 1013088 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO