BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10369004 · Received August 5, 2020

    Report

    Report Number
    1221359-2020-00199
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    June 14, 2020
    Report Date
    August 4, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) INC. ON RETAINED KIT LOT M120401 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 M120401 AND TEST BASE PART NUMBER 190-430 / LOT M120401 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M120401 SHOWED THAT THE COMPLAINT RATE IS (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

    A CUSTOMER REPORTED TEN (10) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS PATIENT FIVE (5) OF TEN (10). A CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON A DIRECT NASAL KITTED SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020. NO ADDITIONAL TESTS WERE PERFORMED USING THE ID NOW COVID-19 ASSAY. CONFIRMATION TESTING WAS PERFORMED ON A NEW COMBINED NASOPHARYNGEAL (NP) AND OROPHARYNGEAL SWAB IN UNIVERSAL TRANSPORT MEDIA (UTM) USING THE BD MAX PCR. ADDITIONAL CONFIRMATION TEST WAS PERFORMED USING A NP SWAB IN UTM USING GENMARK PCR. RESULTS WERE NOT PROVIDED FOR EITHER CONFIRMATION TEST. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE ID NOW COVID-19 TEST RESULT. THE PATIENT'S TREATMENT WAS NOT IMPACTED AND/OR DELAYED. THE PATIENT WAS SYMPTOMATIC (NOT FURTHER SPECIFIED). INFORMATION REGARDING TREATMENT AND OUTCOME WERE NOT PROVIDED. 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. ADDITIONALLY, THE PI 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. ADDITIONALLY, THE ID NOW COVID-19 PRODUCT INSERT INCLUDES A LIMITATION THAT FALSE NEGATIVE RESULTS MAY OCCUR IF A SPECIMEN IS IMPROPERLY COLLECTED, TRANSPORTED OR HANDLED. 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. DUE TO THE RISK OF A FALSE NEGATIVE RESULT POTENTIALLY LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831814 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M120401 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR