BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11178760 · Received January 15, 2021

    Report

    Report Number
    1221359-2021-00095
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 15, 2020
    Report Date
    March 22, 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
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6 TYPE OF INVESTIGATION: 4106. ADDITIONAL INFORMATION: THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 190-000 / LOT NUMBER 1003575 AND M127005 AND TEST BASE PART NUMBER 190-430 / LOT 1003575 AND M127005. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT M127005 BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN THE PACKAGE INSERT RELATED TO %TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION. 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 SAMPLES.

    Additional Manufacturer Narrative · 1

    RETAIN TESTING: TESTED THE ID NOW COVID-19 RETAIN TEST KIT LOT M127005WITH 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 POSITIVE RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. 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 A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020 ON A DIRECT TESTED NASAL SWAB. THE SPECIMEN WAS SELF-COLLECTED. A SECOND COVID TEST FROM THE UNIVERSITY OF WASHINGTON GENERATED A RESULT OF NEGATIVE ON A PCR. ON (B)(6) 2020, THE THIRD COVID TEST WAS COMPLETED ON THE QUIDEL SOFIA 1 WITH A POSITIVE RESULT. THE PATIENT RETURNED TO THE UNIVERSITY OF WASHINGTON FOR A 4TH TEST WITH AN UNKNOWN RESULT. ALTHOUGH REQUESTED, CT VALUES, ADDITIONAL PATIENT INFORMATION INCLUDING TREATMENT AND OUTCOME WERE 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
    77853 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M127005 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1