BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15728909 · Received November 4, 2022

    Report

    Report Number
    1221359-2022-05225
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 25, 2022
    Report Date
    January 27, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1075371 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 KIT PART NUMBER 191-000 / LOT 1075371 AND TEST BASE PART NUMBER 190-430 / LOT 1075371. 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 1075371 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE DELETED PRIOR TO THE REPORTED DATE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SIMILAR PRODUCT TO 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON A DIRECT TESTED (B)(4) TECHNOLOGY CO. LTD DISPOSAL SAMPLING SWAB (TYPE A-04-80) NASOPHARYNGEAL SAMPLE ON (B)(6) 2022. CONFIRMATION PCR TESTING (LIAISON MDX) WAS PERFORMED THE SAME DAY WITH A DIFFERENT SAMPLE WHICH GENERATED A NEGATIVE RESULT. A THIRD SAMPLE, WHICH WAS COLLECTED ON (B)(6) 2022, WAS SENT TO THE REGIONAL REFERENCE CENTER FOR TESTING AND GENERATED A NEGATIVE RESULT ON (B)(6) 2022. THE PATIENT WAS REPORTED TO HAVE HAD A FEVER AT THE TIME OF TESTING. AS A RESULT OF THE INITIAL POSITIVE ID NOW RESULT, THE PATIENT WAS PLACED IN THE COVID-19 CLINIC FOR MORE THAN SIX HOURS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497796 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1075371 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown