BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12257079 · Received July 31, 2021

    Report

    Report Number
    1221359-2021-02181
    Event Type
    Malfunction
    Date Received
    July 31, 2021
    Date of Event
    March 31, 2021
    Report Date
    July 30, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1013538 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 1013538, TEST BASE PART NUMBER 190-430 /LOT 1013538. 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 1013538 SHOWED THAT THE COMPLAINT RATE IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THEID NOW COVID-19 PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL KITTED SWAB. THE NASOPHARYNGEAL SWAB WAS USED TO SWAB BOTH NOSTRILS. REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 WITH A NEW NASOPHARYNGEAL SWAB USING THE ID NOW COVID-19 GENERATED NEGATIVE RESULTS. ROCHE Z480 RT-PCR -CONFIRMATION TESTING ON NASOPHARYNGEAL SWAB ELUTED INTO VTM GENERATED POSITIVE RESULTS (CT VALUES =36, E GENE). THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154253 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013538 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1