BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 13502254 · Received February 9, 2022

    Report

    Report Number
    1221359-2022-00814
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 15, 2022
    Report Date
    March 15, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR REPORTS: 1221359-2022-00810, 1221359-2022-00811, 1221359-2022-00812, 1221359-2022-00813.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1038045 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 1038045 AND TEST BASE PART NUMBER 190-430 / LOT 1038045. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1038045 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. REFERENCE MFR REPORTS: 1221359-2022-00810 THROUGH 1221359-2022-00814.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FIVE (5) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR FIVE PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT FIVE (5) AND IS FIVE (5) OF FIVE (5). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 TESTED DIRECTLY ON A NASAL KITTED SWAB. ON (B)(6) 2022, PCR CONFIRMATION TESTING WITH SEEGENE PCR (ALLPLEX KIT) AT UNIVERSITY HOSPITAL WISHAW (NHS LANARKSHIRE) GENERATED A POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. BUT PATIENTS MOVED TO NON-COVID WARDS BASED ON IDNOW ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850378 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1038045 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown