BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11822173 · Received May 13, 2021

    Report

    Report Number
    1221359-2021-01468
    Event Type
    Injury
    Date Received
    May 13, 2021
    Report Date
    August 11, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT: 1022441 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: 1022441, TEST BASE PART NUMBER: 190-430/ LOT: 1021441. 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: 1022441 SHOWED THAT THE COMPLAINT (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT: 1022441 SHOWED THAT THE COMPLAINT (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOG FILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. REPORT : 1221359-2021-01466 (PATIENT 1) AND 1221359-2021-01467 ( PATIENT 2). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED (3) DISCREPANT RESULTS ON THE ID NOW COVID-19 ASSAY, WHICH OCCURRED ON VARIOUS DATES AND WAS OBSERVED BETWEEN THE EMERGENCY ROOM AND THE LABORATORY. THIS REPORT ADDRESSES PATIENT (3) OF (3). PER THE CUSTOMER DISCREPANT RESULTS WERE RECEIVED FROM DIRECT KITTED SWABS WHILE USING THE IDNOW COVID-19 ASSAY. THE PATIENTS WERE NOTED TO BE ASYMPTOMATIC AND SYMPTOMATIC, NO SPECIFIC STATUS WAS PROVIDED FOR EACH PATIENT. THE CUSTOMER CONFIRMED THE PATIENT DID NOT HAVE A HISTORY OF TESTING POSITIVE FOR COVID-19. THE CUSTOMER REPORTED THE PATIENT'S MEDICAL CARE WAS IMPACTED. THE PATIENT SUBSEQUENTLY RECEIVED TREATMENT FOR COVID-19 INFECTION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713601 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022441 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other