BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12243393 · Received July 28, 2021

    Report

    Report Number
    1221359-2021-02132
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    March 7, 2021
    Report Date
    November 15, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1022272 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: 1022272 , TEST BASE PART NUMBER 190-430 / LOT: 1022272 . 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 1022272 SHOWED THAT THE COMPLAINT RATE IS (B)(4). BBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. PER THE CUSTOMER, THE PATIENT IS OF (B)(6) ETHNICITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A DIRECT TESTED NASOPHARYNGEAL SWAB WITH ID NOW COVID-19 ASSAY. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 WITH CEPHEID PCR ON A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIA AND GENERATED NEGATIVE RESULTS. PER THE CUSTOMER, AS A RESULT OF THE FALSE POSITIVE, THE PATIENT WAS ADMITTED TO AN INTENSIVE CARE UNIT (ICU) COHORT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138773 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 ASSAY QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1022272 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization