BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12081778 · Received June 28, 2021

    Report

    Report Number
    1221359-2021-01834
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 30, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ABBOTT DAIGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ESTABLISHMENT TELEPHONE NUMBER : (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1025677 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: 1025677, TEST BASE PART NUMBER 191-430 / LOT: 1025677. 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 1025677 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON A NASOPHARYNGEAL SAMPLE WITH ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021. REPEAT TESTING MULTIPLE TIMES GENERATED NEGATIVE RESULTS. PCR ( BOSCH) CONFIRMATION TESTING GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED PATIENT WAS VACCINATED IN (B)(6). NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977526 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DAIGNOSTICS SCARBOROUGH, INC. 1025677 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1