BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12164306 · Received July 13, 2021

    Report

    Report Number
    1221359-2021-01991
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Report Date
    August 20, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1023594 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 NUMBER190-000 / LOT 1023594 AND TEST BASE PART NUMBER 190-430 / LOT 1023594. 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 1028103 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED. REVIEW OF COMPLAINTS AGAINST THE KIT LOTS FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND HAVE NOT IDENTIFIED A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REFERENCE MFR NUMBERS: 1221359-2021-01990, 1221359-2021-01992, 1121359-2021-01963.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT THREE (3) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053623 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH 1023594 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1