BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12751882 · Received November 4, 2021

    Report

    Report Number
    1221359-2021-03396
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M162309 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 190-000J / LOT: M162309, TEST BASE PART NUMBER 190-430 / LOT: M162309. 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 M162309 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR REPORT: 1221359-2021-03395.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON TWO (2) DATES. THIS MFR. REPORT ADDRESSES REPORT TWO (2) OF TWO (2) FOR THE FALSE POSITIVE RESULTS PERFORMED ON (B)(6) 2021. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021. AN ANTIGEN TEST WAS PERFORMED AND GENERATED NEGATIVE RESULTS. PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED NEGATIVE (CT VALUE NOT PROVIDED). ALTHOUGH REQUESTED, ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653015 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M162309 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown