BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11382922 · Received February 25, 2021

    Report

    Report Number
    1221359-2021-00578
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 22, 2021
    Report Date
    March 29, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1013538 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 191-000 / LOT 1013538 AND TEST BASE PART NUMBER 191-430 / LOT 1013538. THE QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1013538 SHOWED THAT THE COMPLAINT RATE IS (B)(4). INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    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

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON A DIRECT TESTED NASOPHARYNGEAL SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING ON SAMPLE COLLECTED (B)(6) 2021 WITH SEEGENE PCR KIT (GENE E, GENE N, GENE RDRP) PERFORMED (B)(6) 2021 PROVIDED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH RIGHT ABDOMINAL PAIN, DIAGNOSED WITH ACUTE APPENDICITIS AND UNDERWENT EMERGENCY APPENDECTOMY. THE PATIENT WAS NOT SYMPTOMATIC AT THE TIME OF TESTING AND HAD NO CLOSE CONTACTS AND NO TRAVEL HISTORY. THE CUSTOMER STATED THAT THEY USE RAPID MOLECULAR ID NOW AS THEIR PRIMARY PLATFORM TO SCREEN THEIR PATIENTS WHO COME FOR ADMISSION/INPATIENT AND ALL PROCEDURE CASES BECAUSE, THE RESULTS ARE FASTER THAN RT-PCR, AND MATCHES THEIR PATIENT VOLUME IN TRANSITING PATIENTS IN INFLUENZA-LIKE ILLNESS (ILI) AND SEVERE ACUTE RESPIRATORY INFECTION (SARI) WARD/COVID WARD/NORMAL WARD. A PATIENT DOES NOT NEED TO WAIT IN EMERGENCY OR ILI/SARI WARD IF THE COVID RESULT IS NEGATIVE AND THEY CAN MOVE INTO THE NORMAL WARD. THE TURN-AROUND TIME FOR RT-PCR IS 24 HOURS TO 48 HOURS. TRANSITING FROM ONE WARD TO ANOTHER IS ALSO CONSIDERED AS COSTING FOR PATIENTS AND REPEATING TESTS IS A COSTING FOR HOSPITAL MANAGEMENT. 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. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275347 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013538 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other