BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11681103 · Received April 16, 2021

    Report

    Report Number
    1221359-2021-01023
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 15, 2021
    Report Date
    July 21, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1007515 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 1007515, TEST BASE PART NUMBER 190-430/LOT 1007515 . 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 1007515 SHOWED THAT THE COMPLAINT RATE (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES DID NOT CONTAIN DATA FOR THE DATES PROVIDED.

    Additional Manufacturer Narrative · 1

    REFERENCE MANUFACTURER REPORTS:1221359-2021-01021 & 1221359-2021-01022.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR (3) PATIENTS PERFORMED ON DIFFERENT DATES THIS MFR. REPORT ADDRESSES PATIENT 3 OF 3. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT FOR PATIENT 3 WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL SWAB. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION PCR TESTING (CEPHEID PCR + ALTONA PCR) ON (B)(6) 2021, AND TWICE ON (B)(6) 2021 USING NASOPHARYNGEAL SWABS IN VIRAL TRANSPORT MEDIA GENERATED NEGATIVE RESULTS. IT WAS ALSO REPORTED COVID SEROLOGY (IGG) WAS POSITIVE FOR THIS PATIENT. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. THE PATIENT WAS TESTED IN THE EMERGENCY ROOM. PER THE CUSTOMER, THE PATIENT IMPACT WAS ADMISSION TO ICU COHORTING AREA. ADDITIONAL INFORMATION IS BEING REQUESTED. IN THE ABSENCE OF ADDITIONAL INFORMATION AT THIS TIME, THIS EVENT IS BEING REPORTED AS BOTH A PRODUCT MALFUNCTION AND SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576686 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1007515 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization