BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11374114 · Received February 24, 2021

    Report

    Report Number
    1221359-2021-00550
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1018715 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 1018715 AND TEST BASE PART NUMBER 191-430 / LOT 1018715. 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 1018715 SHOWED THAT THE COMPLAINT RATE IS 0.02%. 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

    REFER TO MRN: 1221359-2021-00549. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS PATIENT TWO OF TWO. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON DIRECT TESTED NASOPHARYNGEAL SWAB SAMPLES WITH THE ID NOW COVID-19 ASSAY. REPEAT TESTING WITH THE ID NOW COVID-19 ASSAY WAS NOT PERFORMED. CONFIRMATION TESTING WITH PCR PROVIDED NEGATIVE RESULTS. SWAB TYPE, USE OF VIRAL TRANSPORT MEDIA, AND DATES OF COLLECTION/TESTING WERE NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH, SERIOUS INJURY, OR TREATMENT DELAY/IMPACT BASED ON THE ID NOW COVID-19 ASSAY RESULTS. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF TESTING. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. 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
    269137 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1018715 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR