BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12022218 · Received June 17, 2021

    Report

    Report Number
    1221359-2021-01796
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 18, 2021
    Report Date
    August 17, 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
    GT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 191-000 / 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 POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1025739 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: 1221359-2021-01795.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE REPORT: 1221359-2021-01795.

    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 AND (B)(6) 2021 . THIS MFR. REPORT ADDRESSES PATIENT TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 PERFORMED ON 18M (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL SWAB (COPAN BRAND POLYESTER SWAB). REPEAT TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. RT-PCR CONFIRMATION TESTING ON NASOPHARYNGEAL SWABS WITH GENEXPERT PLATFORM GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC,DIAGNOSED POSITIVE FOR COVID-19 IN (B)(6) 2020 AND HAD FIRST DOSE OF (B)(6) VACCINE IN (B)(6) 2021 . ADDITIONALLY, CUSTOMER CONFIRMED PATIENT HAD CONTACT WITH A POSITIVE COVID-19 PATIENT, 24 HOURS PRIOR TO THE CONSULTATION . PER THE CUSTOMER, NO PATIENT HARM OCCURRED DUE TO THE FALSE RESULT. HOWEVER, DECISION MAKING WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911265 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