BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11346126 · Received February 18, 2021

    Report

    Report Number
    1221359-2021-00519
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 18, 2021
    Report Date
    February 17, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1013573 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 191-000 / LOT 1013573 AND TEST BASE PART NUMBER 191-430 / LOT 1013573 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 1013573 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; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS, AND POSSIBLY A THIRD WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER COULD NOT REMEMBER IF THERE ACTUALLY WAS A THIRD PATIENT WITH A FALSE POSITIVE RESULT. THIS REPORT REPRESENTS PATIENT TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A THROAT SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021 AT 2331. CONFIRMATORY PCR TESTING ON (B)(6) 2021 ALSO PROVIDED NEGATIVE RESULTS. AT 0808 ON (B)(6) 2021, REPEAT TESTING WITH THE ID NOW COVID-19 ASSAY PROVIDED NEGATIVE RESULTS. SWAB TYPE AND USE OF VIRAL TRANSPORT MEDIA WERE NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH BASED ON THE RESULTS OF THE ID NOW COVID-19 ASSAY RESULTS. THERE WAS NO DELAY IN OR INAPPROPRIATE MEDICAL TREATMENT OR TREATMENT BASED ON THE RESULTS. THE PATIENT WAS QUARANTINED, AND LOST AN UNSPECIFIED SERVICE. 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. 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
    240448 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013573 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1