BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11355540 · Received February 19, 2021

    Report

    Report Number
    1221359-2021-00532
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    January 6, 2021
    Report Date
    March 19, 2021
    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

    REFER TO MRN: 1221359-2021-00530, 1221359-2021-00531, 1221359-2021-00533, 1221359-2021-00534. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) , INC. ON RETAINED KIT LOT M133949 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000 / LOT M133949 AND TEST BASE PART NUMBER 190-430 / LOT M133949 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 M133949 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. 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 SENT A CUMULATIVE REPORT OF FOURTEEN FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY GENERATED ACROSS DIFFERENT TESTING SITES. THIS REPORT REPRESENTS ONE FALSE NEGATIVE ASSOCIATED WITH LOT # M133949. THIS IS REPORT THREE OF FIVE. THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS USING A NASAL SWAB WITH THE ID NOW COVID-19 TEST. SPECIMEN COLLECTION OCCURRED ON (B)(6) 2021; TESTING DATE IS UNKNOWN. CONFIRMATION TESTING WITH A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIA WITH ABBOTT M2000 PLATFORM PROVIDED POSITIVE RESULTS (SPECIMEN COLLECTION/TESTING DATES NOT PROVIDED). ADDITIONAL PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT AND OUTCOME, IS UNKNOWN. NO ADDITIONAL INFORMATION WILL BE 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. 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
    244972 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M133949 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1