BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11235752 · Received January 27, 2021

    Report

    Report Number
    1221359-2020-00319
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    September 9, 2020
    Report Date
    January 27, 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

    INITIAL MDR'S 1221359-2020-00319; 1221359-2020-00320; 1221359-2020-00321 SENT AS 'ELECTRONIC SUBMISSION' SUBMISSION TYPE THROUGH THE WEBTRADER ELECTRONIC SUBMISSIONS GATEWAY AND WAS NOT SENT TO THE EMDR SYSTEM. THIS WAS IDENTIFIED ON (B)(6) 2021. THIS REPORT (1221359-2020-00319) AND RELATED REPORTS 1221359-2020-00320 AND 1221359-2020-00321 WERE RESUBMITTED AS SUBMISSION TYPE: ADVERSE EVENT IN THE WEBTRADER ELECTRONIC SUBMISSIONS GATEWAY (B)(6) 2020. THE FOLLOW-UP REPORTS REPRESENT A CORRECTION TO DATE OF REPORT AND IDENTIFICATION OF INITIAL ERROR.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M124819 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 M120548 AND TEST BASE PART NUMBER 190-430 / LOT M124819 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 M124819 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. 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 SENT A CUMULATIVE REPORT OF THREE (3) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS ONE (1) OF THREE (3) A CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH A DIRECT NASAL SWAB SAMPLE (SWAB TYPE NOT OTHERWISE SPECIFIED) ON THE ID NOW COVID-19 ASSAY. SPECIMEN COLLECTION OCCURRED ON (B)(6) 2020; TESTING DATE AND TIME IS UNKNOWN. ADDITIONAL TESTING ON A NASOPHARYNGEAL (NP) SWAB ELUTED IN VTM (SWAB AND VTM TYPE NOT OTHERWISE SPECIFIED) WAS POSITIVE BY THE ABBOTT M2000. CONFIRMATION SPECIMEN COLLECTION OCCURED (B)(6) 2020; TESTING DATE AND TIME IS UNKNOWN. ADDITIONAL PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT, IMPACT AND OUTCOME WAS UNKNOWN. ATTEMPTS TO GAIN FURTHER INFORMATION WERE UNSUCCESSFUL. 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. 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
    131629 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M124819 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1