BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19

    MDR report key: 11579775 · Received March 27, 2021

    Report

    Report Number
    1221359-2021-00821
    Event Type
    Injury
    Date Received
    March 27, 2021
    Date of Event
    February 25, 2021
    Report Date
    June 28, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D3, G1. H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1011578 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000 / LOT: 1011578 , TEST BASE PART NUMBER 190-430 / LOT: 1011578 . THE 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 1011578 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS ON DIRECT TESTED KITTED SWAB TO COLLECT A NASOPHARYNGEAL SAMPLE WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021. CONFIRMATION TESTING PERFORMED THAT SAME DAY WITH CEPHEID PCR PROVIDED POSITIVE RESULTS (CT VALUE 36.7). THE PATIENT REPORTED TO THE EMERGENCY DEPARTMENT WITH ACUTE SHORTNESS OF BREATH AND CHEST PAIN. THE PATIENT HAD BEEN SYMPTOMATIC FOR LESS THAN 24 HOURS. THE PATIENT WAS AFEBRILE. THE PATIENT'S MEDICAL HISTORY INCLUDED CONGESTIVE HEART FAILURE (CHF) AND DIABETES. AN ELECTROCARDIOGRAM SHOWED ST-ELEVATION, CHEST X-RAY SHOWED BILATERAL OPACITIES CONSISTENT WITH CHF, AND O2 SATURATION 74%. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY, UPON ARRIVAL WAS COVID-19 TESTED BY PCR AND A RELIABLE FAMILY MEMBER INDICATED THAT THE PATIENT HAD BEEN IN CLOSE CONTACT WITH A PERSON DIAGNOSED WITH COVID-19 INFECTION. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE CUSTOMER INDICATED THAT THERE WAS A DELAY IN INTERVENTION AND ADVANCED CARDIAC CARE FOR THE PATIENT IN ACUTE RESPIRATORY FAILURE AND HYPOXIA WITH SECONDARY CARDIAC EVENT (ST ELEVATION MYOCARDIAL INFARCTION). 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
    476607 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1011578 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other