BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10382158 · Received August 7, 2020

    Report

    Report Number
    1221359-2020-00218
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    June 29, 2020
    Report Date
    August 7, 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 M120208 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 M120208 AND TEST BASE PART NUMBER 190-430 / LOT M120208 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 M120208 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 TWO (2) PATIENTS WITH THE ID NOW COVID-19 TEST. THIS REPORT REPRESENTS ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT FROM A DIRECT NASAL KITTED SWAB IN BOTH NOSTRILS USING THE ID NOW COVID-19 TEST PERFORMED ON (B)(6) 2020. NO ADDITIONAL TESTS WERE PERFORMED USING THE ID NOW COVID-19 ASSAY. CONFIRMATION TESTING WAS PERFORMED WITH A NASOPHARYNGEAL SWAB USING THE ROCHE COBAS 6800 PCR. THE CONFIRMATION TEST GENERATED THE FOLLOWING POSITIVE RESULTS T1: 35.2, T2: 36.2. 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 (B)(6) YEAR-OLD MALE PATIENT HAD BEEN SYMPTOMATIC (NOT FURTHER SPECIFIED) FOR TWO WEEKS. CONCOMITANT MEDICATION INCLUDED ACETAMINOPHEN. NO REMEDIAL ACTION WAS TAKEN. AT THE TIME OF THE REPORT, THE PATIENT HAD 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. 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
    844394 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M120208 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR