BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12174224 · Received July 15, 2021

    Report

    Report Number
    1221359-2021-01989
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 14, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M145666 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: M145666, TEST BASE PART NUMBER 190-430 / LOT: M145666. 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 M145666 SHOWED THAT THE COMPLAINT RATE IS 0.02%. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 PERFORMED ON (B)(6) 2021 ON A FLOQ DIRECT TESTED NASOPHARYNGEAL SWAB SAMPLE. THE CUSTOMER REPORTED THAT THERE WAS A FIVE (5) MINUTE LAG TIME WITH TESTING TIME OF THE CULTURE AS THE SAMPLE WAS STORED INSIDE A STERILE TUBE, THEN FURTHER WRAPPED IN A BAG AND TRANSPORTED TO THE INSPECTION LAB AND TESTED. REPEAT TESTING WAS NOT PERFORMED. PCR CONFIRMATION TESTING WAS PERFORMED (B)(6) 2021 ON A NASOPHARYNGEAL SWABS AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC WITH A COUGH. THE FALSE POSITIVE WAS FOR A DOCTOR AT THE HOSPITAL, HENCE THE DOCTOR TOOK A DAY OFF WORK. NO DELAY WITH TREATMENTS, AS HE WENT BACK TO WORK AFTER CONFIRMING NEGATIVE WITH PCR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072858 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M145666 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown