BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11427469 · Received March 7, 2021

    Report

    Report Number
    1221359-2021-00618
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Report Date
    June 10, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATE: G6: THE TYPE OF REPORT WAS INADVERTENTLY DESIGNATED AS A 5-DAY REPORT UNDER THE INITIAL MDR. THE REPORT IS A 30- DAY REPORT.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1014263 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    MFR REPORTS: 1221359-2021-00609, 1221359-2021-00613, 1221359-2021-00614. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 190-000 / LOT 1014263 AND TEST BASE PART NUMBER 190-430 / LOT 1014263. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS WITH NO FALSE NEGATIVE RESULTS OBSERVED. THE ID NOW COVID-19 RETAIN TEST KIT LOT 1014263 WITH COVID-19 LOD AND A BLANK PATIENT SWAB ELUTED IN ELUTION BUFFER. ALL TESTS WERE RUN IN DUPLICATE, WERE VALID AND PERFORMED AS EXPECTED. NO UNEXPECTED OR FALSE NEGATIVE RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVES FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 7 FALSE NEGATIVE RESULTS FROM THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS LOT FOUR( 4) OF FOUR (4). THE CUSTOMER REPORTED ONE (1) FALSE NEGATIVE ON A NASAL SWAB WHILE USING THE ID NOW COVID-19 ASSAY. CONFIRMATION TESTING ON A NASOPHARYNGEAL SWAB IN TRANSPORT MEDIA USING CORE LAB PLATFORM GENERATED POSITIVE RESULTS ( CT VALUE NOT 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
    327221 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1014263 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1