BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11177986 · Received January 15, 2021

    Report

    Report Number
    1221359-2021-00200
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 17, 2020
    Report Date
    February 16, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1012964 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT 190-000/ LOT 1012964 AND KIT PART NUMBER 190-430 / LOT 1012964. THIS LOT MET THE REQUIRED SPECIFICATIONS. INVESTIGATION IS NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE AND FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1012964 SHOWED THAT THE COMPLAINT RATE IS (B)(4) FOR BOTH. ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER REPORTED POSITIVE RESULTS ON DIRECT TESTED SWABS WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2020 AT 1430. THE KITTED NASAL SWAB WAS USED TO COLLECT SPECIMENS FROM BOTH NOSTRILS. REPEAT TESTING WITH THE ID NOW COVID-19 ASSAY PERFORMED AT 1445 GENERATED NEGATIVE RESULTS. THE PATIENT DID NOT WANT TO BE RETESTED. NO ADDITIONAL/CONFIRMATION TESTING WAS PERFORMED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE ID NOW COVID-19 ASSAY TEST RESULTS. THERE WAS NO IMPACT OR DELAY TO PATIENT TREATMENT. THE PATIENT WAS NOT SYMPTOMATIC AT THE TIME OF TESTING. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA. PER THE ID NOW COVID-19 PRODUCT INSERT, PRECAUTIONS INCLUDE: 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. NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND, IF INCONSISTENT WITH CLINICAL SIGNS AND SYMPTOMS OR NECESSARY FOR PATIENT MANAGEMENT, SHOULD BE TESTED WITH DIFFERENT AUTHORIZED OR CLEARED MOLECULAR TESTS. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS SHOULD BE CONSIDERED IN THE CONTEXT OF A PATIENT'S RECENT EXPOSURES, HISTORY AND THE PRESENCE OF CLINICAL SIGNS AND SYMPTOMS CONSISTENT WITH COVID-19. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74903 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1012964 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1