BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10825958 · Received November 11, 2020

    Report

    Report Number
    1221359-2020-00384
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    September 10, 2020
    Report Date
    November 11, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) INC. ON RETAINED KIT LOT M122668 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 NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M122668 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS PATIENT THREE (3) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A DIRECT TESTED TYPENEX NASOPHARYNGEAL (NP) SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2020. REPEAT TESTING WITH THE ID NOW COVID-19 ASSAY WAS NOT PERFORMED. ON (B)(6) 2020, CONFIRMATION TESTING ON A NP SAMPLE WITH PCR (NOT OTHERWISE SPECIFIED) GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY. IT WAS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THE PATIENT WAS AN IN-HOUSE PATIENT TRANSITIONING TO A NURSING FACILITY. AFTER TESTING POSITIVE, THE PATIENT WAS TRANSFERRED TO A HOSPITAL FLOOR DESIGNATED FOR COVID PATIENTS AND ISOLATED. THE PATIENT'S TRANSITION TO A NURSING FACILITY WAS DELAYED. TREATMENTS OR PATIENT IMPACT WAS UNKNOWN. THE CUSTOMER STATED THAT THE LABORATORY DID AN ENVIRONMENTAL SWAB TESTING OF THE INSTRUMENT, LAB BENCH AREA AND THE PLEXIGLASS SHIELD THEY USE TO COVER THE ID NOW INSTRUMENT. ALL THREE TESTS RETURNED A POSITIVE RESULT. THEY CLEANED USING STERIWIPE 55% ISOPROPYL ALCOHOL (INSTRUMENT, BENCH, AND PLEXIGLASS RESIDENCE TIME OF 2 MINUTE TREATMENT) AND RECOLLECTED SAME ENVIRONMENTAL SAMPLES. SAMPLES ALL TESTED NEGATIVE AT THAT TIME. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA. 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. THIS EVENT SHALL BE CONSIDERED REPORTABLE BECAUSE OF THE HIGH RISK SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289605 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M122668 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR