BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12027958 · Received June 18, 2021

    Report

    Report Number
    1221359-2021-01706
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    April 28, 2021
    Report Date
    June 18, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), 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 190-430 / LOT: 1022562. 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 1022562 SHOWED THAT THE COMPLAINT RATE IS 0.01%. ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOG FILES WERE NOT PROVIDED. INITIAL REPORTER NAME AND ADDRESS: (B)(6). MFR REPORT REFERENCE: 1221359-2021-01707, 1221359-2021-01708, AND 1221359-2021-01709.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR (4) PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT (1) OF (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A SAMPLE IN VIRAL TRANSPORT MEDIA (BD). PCR CONFIRMATION TESTING (XPERT XPRESS SARS-COV-2 [CEPHIED]) ON (B)(6) 2021 GENERATED NEGATIVE RESULT. THE CUSTOMER REPORTED THAT THIS PATIENT WAS MOVED TO COVID-19 WARD DUE TO THE ID NOW POSITIVE RESULT, AS A RESULT IT INCREASED THE RISK FOR THE PATIENT TO BE CONTAMINATED BY COVID-19. ADDITIONALLY,THE CUSTOMER STATED THAT AS FAR AS THEY KNOW, THE PATIENT WAS NOT CONTAMINATED. THE PATIENT WAS DIAGNOSED WITH PYELONEPHRITE AND WAS TREATED WITH LANTUS SOLOSTAR, NOVORAPID, SIMSASTATINE, PARACETAMOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923032 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