BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12022217 · Received June 17, 2021

    Report

    Report Number
    1221359-2021-01795
    Event Type
    Injury
    Date Received
    June 17, 2021
    Report Date
    August 17, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1025959 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 191-000 / LOT 1025959, TEST BASE PART NUMBER 190-430 / LOT 1025959. 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 1025959 SHOWED THAT THE COMPLAINT RATE IS (B)(4) IN CONCLUSION, 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 SAMPLE OR CROSS CONTAMINATION. REFERENCE MFR:REPORT: 1221359-2021-01796.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE REPORT: 1221359-2021-01796.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 FOR TWO (2) PATIENTS PERFORMED RESPECTIVELY ON (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL SWAB (COPAN BRAND POLYESTER SWAB). REPEAT TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING (X2) ON NASOPHARYNGEAL SWABS WITH RT-PCR GENEXPERT & FILMARRAY- BIOFIRE PLATFORMS GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC AND PLANNED TO ADMIT IN THE HOSPITAL FOR A TREATMENT RELATED TO METASTASIS TERMINAL PHASE. THE CUSTOMER REPORTED THE PATIENT COULD NOT BE ADMITTED TO THE HOSPITAL DUE TO THE TEST RESULTS . ADDITIONALLY, THE CUSTOMER CONFIRMED TREATMENT WAS DELAYED SINCE THEY HAD TO WAIT AND DECIDE WHETHER TO ENTER THE COVID AREA OF THE HOSPITAL OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911266 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1025959 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other