BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11721447 · Received April 23, 2021

    Report

    Report Number
    1221359-2021-01224
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    July 18, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE INVESTIGATION CONCLUSION AND ADDITIONAL INFORMATION. CORRECTION: SUBMISSION DATE OF INITIAL REPORT 23APR2021. INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M140329 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 TEST KIT PART NUMBER 190-000 / LOT M140329, TEST BASE PART NUMBER 190-430 / LOT M140329. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M140329 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. THE CUSTOMER REPORTED THAT APPROXIMATELY THREE AND A HALF MINUTES AFTER THE START OF THE TEST, IT WAS JUDGED POSITIVE. IMMEDIATELY AFTER THAT, THE ANTIGEN KIT (DENKA QUICK NAVI COVID19AG) WAS USED AND NEGATIVE RESULTS WERE OBTAINED. THE PATIENT HAD BEEN DIAGNOSED WITH THE CORONAVIRUS INFECTION IN 2020, SO THE CUSTOMER JUDGED THE TEST POSITIVE AND TRANSFERRED THE PATIENT TO ANOTHER HOSPITAL. AT THE TRANSFER CENTER, PCR CONFIRMATION TESTING WAS PERFORMED USING A BD FLOQ NASOPHARYNGEAL SWAB IN THE PHARYNX ON THE DAY OF TRANSFER AND IN THE SPUTUM THE NEXT DAY, AND NEGATIVE RESULTS WERE OBTAINED . A FALSE POSITIVE WAS DETERMINED AT THE HEALTH CENTER. THE CUSTOMER STATED THAT THE PATIENT WAS SYMPTOMATIC: SAT DECREASED (ROOM 85%), BODY TEMPERATURE 36.5 DEGREES. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. HOWEVER, THE CUSTOMER REPORTED THAT THE PATIENT'S TREATMENT WAS DELAYED DUE TO THE PCR TEST BEING PERFORMED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612265 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M140329

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR