BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11429443 · Received March 7, 2021

    Report

    Report Number
    1221359-2021-00679
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Date of Event
    January 27, 2021
    Report Date
    April 28, 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 · 0

    ADDITIONAL/CORRECTED INFORMATION: D3, G1. H10: ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    REFER TO MRN: 1221359-2021-00680. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1012791 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 1012791 AND TEST BASE PART NUMBER 190-430 / LOT 1012791 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1012791 SHOWED THAT THE COMPLAINT RATE IS (B)(4). INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER SENT A CUMULATIVE REPORT OF THREE FALSE NEGATIVE RESULTS INVOLVING TWO LOT NUMBERS WITH THE ID NOW COVID-19 ASSAY GENERATED ACROSS THREE DIFFERENT TESTING SITES. THIS REPORT REPRESENTS LOT NUMBER 1012791. THIS IS REPORT ONE OF TWO. THE CUSTOMER REPORTED ONE FALSE NEGATIVE RESULT USING A NASAL SWAB WITH THE ID NOW COVID-19 TEST. SPECIMEN COLLECTION OCCURRED ON (B)(6) 2021; TESTING DATE AND TIME IS UNKNOWN. CONFIRMATION TESTING WITH A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIA WITH (B)(6) PROVIDED POSITIVE RESULTS. SPECIMEN COLLECTION OCCURRED ON (B)(6) 2021; TESTING DATE AND TIME IS UNKNOWN. 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 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
    325550 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1012791 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1