BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10603160 · Received September 29, 2020

    Report

    Report Number
    1221359-2020-00298
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 29, 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
    IN, 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 M122124 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 M122124 AND TEST BASE PART NUMBER 190-430 / LOT M122124 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 M122124 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 FALSE NEGATIVE RESULTS ON THREE (3) PATIENTS WITH ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON A DIRECT NASAL SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020. THE NASAL SWAB PROVIDED IN THE KIT WAS USED TO SWAB BOTH NOSTRILS PER THE PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING ON A NASOPHARYNGEAL SWAB WITH HOLOGIC PANTHER GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED). THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE ID NOW COVID-19 RESULTS. THE PATIENT'S TREATMENT WAS NOT IMPACTED OR DELAYED BASED ON THE ID NOW COVID-19 RESULTS. THE PATIENT WAS ASYMPTOMATIC, RECEIVED NO TREATMENT, AND WAS REPORTED TO HAVE RECOVERED WELL. 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 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 POTENTIAL FALSE NEGATIVE RESULT LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068059 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M122124 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR