BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11890347 · Received May 26, 2021

    Report

    Report Number
    1221359-2021-01564
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 19, 2021
    Report Date
    August 17, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1022562 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: 1022562, TEST BASE PART NUMBER 130-430/LOT: 1020562 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 1022562 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.

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. REPORT : 1221359-2021-01563 ( PATIENT 1), 1221359-2021-01565 ( PATIENT 3) , 1221359-2021-01566 ( PATIENT 4). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS MFR. REPORT ADDRESSES PATIENT TWO (2) OF FOUR (4). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID -19 ASSAY PERFORMED ON (B)(6) 2021 ON A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIA ( CITOTEST LABWARE). REPEATING TESTING WAS NOT PERFORMED ON THE ID NOW . PCR CONFIRMATION TESTING ON CEPHEID GENEXPERT PLATFORM GENERATED POSITIVE RESULTS. ( CT VALUE : 26 ( GENE N2) AND 24 ( GENE E) ) . THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC WITH FEVER, FATIGUE, COUGH, CHEST TIGHTNESS, DESATURATION. AS PER THE CUSTOMER, PATIENT WAS KNOWN AS COVID-19 POSITIVE AND WAS SENT BACK HOME WITH OXYGEN . THE CUSTOMER CONFIRMED NO PATIENT HARM DUE TO THE FALSE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786176 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022562 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR