BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11177533 · Received January 15, 2021

    Report

    Report Number
    1221359-2021-00190
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 21, 2020
    Report Date
    February 26, 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
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTED DATA: AFTER FURTHER REVIEW OF THE RECORD IT WAS IDENTIFIED THAT UNSPECIFIED CONFIRMATION TESTING PERFORMED (B)(6) 2020 PROVIDED NEGATIVE RESULTS. THE PATIENT UNDERWENT THE SCHEDULED SURGERY. THIS WAS INADVERTENTLY OMITTED FROM THE INITIAL MDR. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M123120 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M123120 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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 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.

    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 M123120 AND TEST BASE PART NUMBER 190-430 / LOT M123120 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION IS COMPLETE. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER REPORTED A POSITIVE RESULT FROM A DIRECT KITTED NASAL SWAB WITH THE ID NOW COVID-19 TEST PERFORMED ON (B)(6) 2020 AT 2:23PM. REPEAT TESTING USING THE SAME SAMPLE RECEIVER WITH THE ID NOW COVID-19 ASSAY AT 2:39PM THAT SAME DAY GENERATED NEGATIVE RESULTS. NO INFORMATION RELATED TO CONFIRMATORY TESTING WAS PROVIDED. THE CUSTOMER CONFIRMED NO DEATH OR SERIOUS INJURY OCCURRED BASED ON THE ID NOW COVID-19 RESULT, BUT INDICATED THAT RESULTS COULD HAVE HAD AN IMPACT ON THE OCCURRENCE OF A SCHEDULED SURGICAL PROCEDURE. PER THE ID NOW COVID-19 PRODUCT INSERT, PRECAUTIONS INCLUDE: DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. HANDLE SAMPLES ACCORDING TO STANDARD LABORATORY PRACTICES. CLEAN INSTRUMENTS AND SURROUNDING SURFACES ACCORDING TO INSTRUCTIONS PROVIDED IN THE CLEANING SECTION OF THE INSTRUMENT USER MANUAL. REFER TO SECTION 1.6, MAINTENANCE & CLEANING, FOR FURTHER INFORMATION. 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 PRODUCT INSERT 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. 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. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS A MALFUNCTION, AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75277 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH INC. M123120 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1