BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11179967 · Received January 15, 2021

    Report

    Report Number
    1221359-2021-00061
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 19, 2020
    Report Date
    March 3, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 190-000 / LOT 1010958 AND TEST BASE PART NUMBER 190-430 / LOT 1010958. THE QUALITY CONTROL RELEASE TESTING IS ACCEPTABLE UNDER RELEASE SPECIFICATIONS. THE RETAIN KIT LOT 1010958 WAS TESTED WITH THE ABBOTT DIAGNOSTICS (B)(4) LIMIT OF DETECTION (LOD) AND A BLANK PATIENT SWAB ELUTED IN ELUTION BUFFER. ALL TESTS WERE VALID AND PERFORMED AS EXPECTED WITH NO FALSE POSITIVE RESULTS REPLICATED. THE LOG FILES FOR ONE (OUT OF TWO) INSTRUMENTS WAS SUBMITTED TO ABBOTT DIAGNOSTICS (B)(4) AND WERE REVIEWED FOR FALSE POSITIVE ID NOW COVID-19 PATIENT TESTS OCCURRING ON (B)(6) 2020. THE FOLLOWING WAS NOTED: VALID POSITIVE RESULT WITH NO ERRORS OR ISSUES OBSERVED. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 1

    CORRECTION: PART NUMBER UPDATED TO 191-000. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1010955 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS, ONE ON A QC AND ANOTHER ON A PATIENT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020, AND ANOTHER FALSE POSITIVE RESULT ON (B)(6) 2020. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION REGARDING THE SAMPLE TYPE SWAB, REPEAT TESTING, AND CONFIRMATION TESTING WERE 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
    73890 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1010958 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1