BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11118911 · Received January 5, 2021

    Report

    Report Number
    1221359-2021-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Report Date
    January 5, 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

    ALTHOUGH THE INVESTIGATION IS STILL IN PROGRESS, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000 / LOT 1010479 AND TEST BASE PART NUMBER 190-430 / LOT 1010479 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 1010479 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PLEASE SEE RELATED MFR REPORT #S: 1221359-2021-00004 - 1221359-2021-00009.

    Description of Event or Problem · 1

    A CUSTOMER SENT A CUMULATIVE REPORT OF SEVENTEEN FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY GENERATED ACROSS EIGHT DIFFERENT TESTING SITES. THIS REPORT REPRESENTS THE SEVEN FALSE NEGATIVES ASSOCIATED WITH LOT # 1010479. THE CUSTOMER REPORTED SEVEN FALSE NEGATIVE RESULTS USING A NASAL SWAB WITH THE ID NOW COVID-19 TEST. TESTING DATES AND TIMES WERE NOT PROVIDED, HOWEVER, SAMPLE COLLECTION OCCURRED ON THE FOLLOWING DATES: (B)(6) 2020. CONFIRMATION TESTING DATES AND TIMES WERE ALSO NOT PROVIDED. HOWEVER, CONFIRMATORY NASOPHARYNGEAL SAMPLE COLLECTION IN VIRAL TRANSPORT MEDIA USING THE CORE LAB PLATFORM PROVIDED POSITIVE RESULTS (CT VALUES NOT PROVIDED). COLLECTION OCCURRED ON THE FOLLOWING DATES: (B)(6) 2020. FOR BOTH THE (B)(6) 2020 AND (B)(6) 2020 COLLECTION DATES, SAMPLE COLLECTION FOR CONFIRMATION WAS IDENTICAL BUT USED THE ABBOTT M2000 PLATFORM THAT PROVIDED POSITIVE RESULTS (CT VALUES NOT PROVIDED). ADDITIONAL PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT AND OUTCOME, IS UNKNOWN. PER THE CUSTOMER, 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
    12646 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH INC. 1010479 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1