BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12643727 · Received October 15, 2021

    Report

    Report Number
    1221359-2021-03181
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 20, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE MFR. REPORT NUMBER: 1221359-2021-03180.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1035029 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: 1035029, TEST BASE PART NUMBER 190-430 / LOT: 1035029. 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 1035029 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A LOG FILE REVIEW WAS CONDUCTED; HOWEVER, THE INFORMATION FOR THE REPORTED TEST DATES (B)(6) 2021 TO (B)(6) 2021 HAD BEEN DELETED BY THE CUSTOMER AND WAS NOT AVAILABLE FOR REVIEW. IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES DID NOT CONTAIN TEST DATE INFORMATION FOR INVESTIGATION. A HISTORICAL REVIEW OF COMPLAINTS AGAINST THE KIT LOTS FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND HAS NOT IDENTIFIED A PRODUCT DEFICIENCY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT 1 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 (09:11 ) ON A DIRECT TESTED NASAL SWAB. THE CUSTOMER REPORTED THAT THESE ARE EMERGENCY ROOM PATIENTS. CONFIRMATION TESTING WAS PERFORMED USING THE HOLOGIC - APTIMA SARS-COV-2 ASSAY (PANTHER SYSTEM) OR CEPHEID XPERT XPRESS SARS-COV-2 ASSAY RAN ON THE CEPHEID GENEXPERT SYSTEM AND ALL TEST GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). THE CUSTOMER REPORTED THAT CONFIRMATORY TESTS WERE PERFORMED BY THE FACILITY'S MICROBIOLOGY DEPARTMENT. IN ADDITION, THE CUSTOMER REPORTED THAT SAMPLES WERE ALSO SENT FOR SEQUENCE ANALYSIS AT THE REFERRAL LAB FOR ALL THE NEW POSITIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER REPORTED THAT IN SOME CASES HOSPITALIZATION OCCURED; HOWEVER, NOT SURE WHETHER THEY WERE HOSPITALISED DUE TO THEIR COVID RESULT OR SYMPTOMS THOUGH. NO SPECIFIC INFORMATION WAS PROVIDED AS TO WHICH PATIENTS WERE HOSPITALIZED, SO THIS NOTE IS BEING ADDED TO ALL RELATED MDRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539780 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19, QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1035029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown