BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10592687 · Received September 28, 2020

    Report

    Report Number
    1221359-2020-00294
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 28, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 123466 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES, AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID, AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS, AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000 / LOT 123466 AND TEST BASE PART NUMBER 190-430 / LOT 123466 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE, AND FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 123466 SHOWED THAT THE COMPLAINT RATES ARE BOTH (B)(4). ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. 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 A POSITIVE RESULT ON A DIRECT NASAL SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020, AT 11:02 AM. THE NASAL SWAB PROVIDED IN THE KIT WAS USED TO SWAB BOTH NOSTRILS PER THE PRODUCT INSERT INSTRUCTIONS. THE CUSTOMER STATED THAT THE PATIENT BECAME "EMOTIONALLY UNSTABLE" AND COMPLAINED. REPEAT TESTING ON A NEW SAMPLE WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2020 AT 1:33 PM GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH, OR SERIOUS INJURY BASED ON THE TEST RESULT. THERE WAS NO IMPACT AND/OR DELAY IN TREATMENT. THE PATIENT WAS ASYMPTOMATIC. NO FURTHER PATIENT INFORMATION WAS PROVIDED. IN THE OPINION OF THE CUSTOMER, THE INITIAL TEST WAS A FALSE POSITIVE AND THE SECOND TEST WAS PRESUMED TRUE NEGATIVE. 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. REFER TO SECTION 1.6, MAINTENANCE & CLEANING, FOR FURTHER INFORMATION. THE ID NOW COVID-19 PRODUCT INSERT INDICATES THAT NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND TESTED WITH AN ALTERNATIVE FDA AUTHORIZED MOLECULAR ASSAY, IF NECESSARY FOR CLINICAL MANAGEMENT, INCLUDING INFECTION CONTROL. THE PRODUCT INSERT STATES NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION. FALSE NEGATIVE RESULTS MAY ALSO OCCUR IF AMPLIFICATION INHIBITORS ARE PRESENT IN THE SPECIMEN OR IF INADEQUATE LEVELS OF VIRUSES ARE PRESENT IN THE SPECIMEN. 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
    1057761 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M123466 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR