BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11668647 · Received April 14, 2021

    Report

    Report Number
    1221359-2021-00968
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 10, 2021
    Report Date
    February 22, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: H10 THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO RETRACT THE PREVIOUS INITIAL MDR REPORT FOR A FALSE POSITIVE OBTAINED WITH DILUTED VIRAL TRANSPORT MEDIA. TESTING USING VTM IS CONSIDERED OFF-LABEL AND ARE NOT SUPPORTED FOR USE BY ABBOTT RAPID DIAGNOSTICS SCARBOROUGH. THE RESULTS OF THIS TEST ARE CONSIDERED TO BE NOT VALID. REF MFR REPORT NUMBERS: 1221359-2021-00966, 1221359-2021-00967, 1221359-2021-00969.

    Additional Manufacturer Narrative · 1

    REFERENCE REPORTS: 1221259-2021-00966, 1221359-2021-00967, AND 1221359-2021-00969 THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR EIGHT (8) PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES EVENT THREE (3) OF FOUR (4) SINCE NO PATIENT DEMOGRAPHICS WERE NOT PROVIDED. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON AN UNKNOWN SAMPLE AND SWAB TYPE FOR ONE (1) PATIENT. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS PERFORMED WITH GENEXPERT PCR AND 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
    560873 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013683 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown