BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12828477 · Received November 17, 2021

    Report

    Report Number
    1221359-2021-03514
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    August 20, 2021
    Report Date
    January 7, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: G3, G6, H2 AND H6. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 190-000/ LOT 1033041 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 190-430 / LOT 1033041 . TEST BASE PART NUMBER 191-000/ LOT 1033041 . 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 1033041 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. A REVIEW OF COMPLAINTS AGAINST THE KIT LOTS FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE MFR. REPORT #S: FOR RELATED FALSE POSITIVES 1221359-2021-03513, 1221359-2021-03514, 1221359-2021-03515, 1221359-2021-03516, 1221359-2021-03517 AND 1221359-2021-03518.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIES DATES. THIS MFR. REPORT ADDRESSES PATIENT 2 OF 6. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED CULTURA NASOPHARYNGEAL SWAB. THE CUSTOMER REPORTED THAT ONE SWAB WAS PERFORMED ON ONE NOSTRIL AND THE SECOND IF THE FIRST WAS POSITIVE WOULD BE COLLECTED FROM THE OTHER, UNUSED NOSTRIL. BOTH SWABS WERE NASOPHARYNGEAL. REPEAT TESTING WAS PERFORMED; HOWEVER, RESULTS WERE NOT PROVIDED. THE CUSTOMER CONFIRMED TESTING BY (B)(6) WAS PCR AND OBTAINED NEGATIVE RESULTS. AFTER, THE FIRST FALSE COUPLE OF FALSE POSITIVES, THE CUSTOMER OPENED A NEW BOX OF SWABS TO REMOVE VARIABLES. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731750 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1033041 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown