BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12155309 · Received July 12, 2021

    Report

    Report Number
    1221359-2021-01928
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    June 13, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1022562 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: 1022562, TEST BASE PART NUMBER 190-430 / LOT: 1022562. 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 1022562 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

    (B)(6) MEDICAL DEVICE VIGILANCE REPORT # (B)(4). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A NASOPHARYNGEAL SWAB .REPEAT TESTING ON (B)(6) 2021 GENERATED NEGATIVE RESULTS. PCR CONFIRMATION TESTING ON NASOPHARYNGEAL SWAB (CITOSWAB) IN VIRAL TRANSPORT MEDIUM WITH GENXPERT SARS-COV-2 ON THE SAME DAY GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC WITH A FEVER AND DYSPNEA. PER THE CUSTOMER, THERE WAS NO PATIENT IMPACT AS CONFIRMATION TESTING WAS PERFORMED IMMEDIATELY AFTER THE IDNOW COVID-19 ASSAY AND NO TREATMENT WAS GIVEN AS THE PATIENT WAS DIAGNOSED AS NEGATIVE FOR COVID-19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051620 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022562 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR