BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 11934403 · Received June 3, 2021

    Report

    Report Number
    1221359-2021-01640
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORT : 1221359-2021-01641, 1221359-2021-01642, 1221359-2021-01643

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1019565 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 190-000 / LOT: 1019565, TEST BASE PART NUMBER 130-430 / LOT: 1019565 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 1021992 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY, WHICH OCCURRED ON VARIOUS DATES AND WITH DIFFERENT LOT NUMBERS. THIS REPORT ADDRESSES LOT ONE (1) OF FOUR (4). THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY. NASAL SWABS WERE COLLECTED ON (B)(6) 2021, (B)(6) 2021. CONFIRMATION TESTING GENERATED POSITIVE RESULTS. THE NASOPHARYNGEAL SAMPLES IN VIRAL TRANSPORT MEDIA WERE COLLECTED ON (B)(6) 2021 (CORELAB), (B)(6) 2021 (ABBOTT M2000), AND (B)(6) 2021 (CORELAB). PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831440 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1019565

    Patients

    Seq Age Sex Outcome Treatment
    1