BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11144202 · Received January 10, 2021

    Report

    Report Number
    1221359-2021-00043
    Event Type
    Malfunction
    Date Received
    January 10, 2021
    Date of Event
    December 10, 2020
    Report Date
    February 24, 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
    501

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M133949 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) 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. REFERENCE MANUFACTURER REPORTS: 1221359-2021-00059.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: UDI. ADDITIONAL INFORMATION / CORRECTED DATA: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    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 NASAL KITTED SWAB. THE NASAL SWAB WAS USED PER THE PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS PERFORMED ON NP SAMPLE IN VIRAL TRANSPORT MEDIA WITH ABBOTT M2000 GENERATED NEGATIVE RESULTS (CT VALUES 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
    41131 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M133949 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1