BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14793811 · Received June 23, 2022

    Report

    Report Number
    1221359-2022-03023
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    January 13, 2022
    Report Date
    June 23, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) . ON RETAINED KIT LOT 1050857 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: 1050857, TEST BASE PART NUMBER 190-430 / LOT: 1050857. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS (B)(4). WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE; SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. REFERENCE MFR. REPORT: 1221359-2022-03024.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR TWO (2) TESTS. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022. CONFIRMATION TESTING VIA A QUIDEL QUICKVUE ANTIGEN HOME TEST ON AN UNKNOWN DATE GENERATED A POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276943 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1050857 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown