BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10532840 · Received September 14, 2020

    Report

    Report Number
    1221359-2020-00270
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 14, 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
    FL, 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 M123759 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 M123759, AND TEST BASE PART NUMBER 190-430 / LOT M123759 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M123759 SHOWED THAT THE COMPLAINT RATES ARE (B)(4) FOR BOTH. 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 REPORTED CONFLICTING RESULTS INVOLVING SIX (6) PATIENTS AND INVOLVING UP TO 24 DEVICES WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS SIX (6) OF SIX (6). THE CUSTOMER REPORTED A POSITIVE RESULT ON A DIRECT NASAL SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020. THE SWABS PROVIDED WITH THE KIT WERE USED TO COLLECT THE NASAL SAMPLE PER THE ID NOW COVID-19 PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING PERFORMED ON A NEW NASAL SAMPLE COLLECTED AND TESTED DIRECTLY 2-3 HOURS LATER, ON A DIFFERENT ID NOW MACHINE, GENERATED NEGATIVE RESULTS. CONFIRMATION TESTING ON DIFFERENT AUTHORIZED OR CLEARED MOLECULAR TEST WAS NOT PERFORMED. NO FURTHER INFORMATION WILL BE PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE TEST RESULTS. THE PATIENT'S TREATMENT WAS NOT IMPACTED OR DELAYED. THE PATIENT WAS NOT SYMPTOMATIC. NO FURTHER PATIENT INFORMATION, INCLUDING TREATMENT, AND OUTCOME, WAS PROVIDED. PER THE ID NOW COVID-19 PRODUCT INSERT, (B)(4), 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. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991190 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M123759 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1