BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12029631 · Received June 18, 2021

    Report

    Report Number
    1221359-2021-01813
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    August 20, 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
    GT
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE INVESTIGATION CONCLUSION AND ADDITIONAL INFORMATION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1025739 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 1025739 TEST BASE PART NUMBER 190-430 / LOT 1025739. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1025739 SHOWED THAT THE COMPLAINT RATE IS 0.004%. ALSO, A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1025739 SHOWED THAT THE COMPLAINT RATE IS 0.0%. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFER TO MFR. REPORT NUMBER: 1221359-2021-01812.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT 2 OF 2. THE CUSTOMER REPORTED A CONFLICTING RESULT WITH A ID NOW COVID-19 ASSAY USED ON A PATIENT THAT WAS ADMITTED TO THE HOSPITAL EMERGENCY ROOM FOR HEAD TRAUMA. THE CUSTOMER REPORTED THAT THE PATIENT DID NOT PRESENT WITH SYMPTOMS SUGGESTIVE OF COVID-19. PRIOR TO THE PATIENT'S TESTING AT THE TIME OF ADMISSION, BOTH THE SCIENTIFIC AND COMMERCIAL ADVISERS HAD A MEETING WITH THE STAFF FROM THE LABORATORY. THE CUSTOMER REPORTED THAT THE PATIENT'S NASOPHARYNGEAL SWAB (COPAN BRAND POLYESTER) SAMPLE WAS TRANSPORTED IN A STERILE TUBE WITHOUT ADDITIVES AND TESTED USING THE ID NOW COVID-19 ASSAY. A POSITIVE RESULT WAS GENERATED. THE CUSTOMER REPORTED THAT THE RESULTS FROM THE PATIENT'S CLINIC WERE QUESTIONABLE AND A DECISION WAS MADE TO PROCESS THE SAMPLE AGAIN IN THE OTHER ID NOW EQUIPMENT PRESENT AT THE INSTITUTION. THIS TIME A NEGATIVE RESULT WAS GENERATED. PER THE CUSTOMER, THE POSITIVE RESULT WAS CONSIDERED TO BE FALSE. PER THE CUSTOMER, THE PATIENT NEEDED IMMEDIATE SURGERY THAT WAS DELAYED DUE TO THE FALSE RESULT AS THERE WAS UNCERTAINTY TO THE HOSPITAL AREA THE PATIENT SHOULD BE ADMITTED SHOULD BE ADMITTED TO. PER THE CUSTOMER, NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922162 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1025739 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Other