BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12164437 · Received July 13, 2021

    Report

    Report Number
    1221359-2021-01962
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Report Date
    April 29, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1020568 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 1020568 AND TEST BASE PART NUMBER 190-430 / LOT 1020568. 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 1020568 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN 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

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REFERENCE MFR NUMBERS: 1221359-2021-01987, 1221359-2021-01986, 1221359-2021-01985, 1221359-2021-01984, 1221359-2021-01983.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF SIX (6). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER REPORTED THAT NASAL SPECIMEN COLLECTION RESULTED IN NEGATIVES WHEN TESTED ON ID NOW. NASOPHARYNGEAL SAMPLES IN VTM WERE SENT TO (B)(6), AND COVID WAS DETECTED ON CONFIRMATION TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053448 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH 1020568 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown