BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19

    MDR report key: 11861296 · Received May 21, 2021

    Report

    Report Number
    1221359-2021-01560
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    April 10, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    PMA / PMN Number
    EU2000074
    Adverse Event
    Yes
    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 1017966 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 1017966 AND TEST BASE PART NUMBER 190-430 / LOT 1017966. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. AA REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1017966 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE: 1221359-2021-01558 1221359-2021-01559, 1221359-2021-01546.

    Description of Event or Problem · 1

    HE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR REPORT ADDRESSES PATIENT FOUR (4) OF FIVE (5). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON DIRECT TESTED NASOPHARYNGEAL SWABS. CONFIRMATION TESTING ON NASOPHARYNGEAL SWABS IN VIRAL TRANSPORT MEDIUM (VTM) WITH PCR SEEGEN GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2021 IN INFECTIOUS DISEASE DEPARTMENT FOR DENGUE DISEASE. BASED ON THE OBSERVED RESULTS THE PATIENT WAS ADMITTED TO THE COVID -19 WARD. THE DENGUE DISEASE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760084 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH 1022566

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR