BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11639484 · Received April 9, 2021

    Report

    Report Number
    1221359-2021-00902
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 8, 2021
    Report Date
    February 11, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA. H10. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1009983 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: 1009983, TEST BASE PART NUMBER 190-430 / LOT: 1009983. 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 1009983 SHOWED THAT THE COMPLAINT RATE IS 0.11%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. REFERENCE MFR NUMBERS: 1221359-2021-00898. 1221359-2021-00899. 1221359-2021-00900. 1221359-2021-00901. 1221359-2021-00904. 1221359-2021-00905. 1221359-2021-00928.

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. REPORT :1221359-2021-00898, 1221359-2021-00899, 1221359-2021-00900, 1221359-2021-00901, 1221359-2021-00903, 1221359-2021-00904 AND 1221359-2021-00905 THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TOTAL OF 27 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2021 USING TWO DIFFERENT LOTS. THIS MFR. REPORT ADDRESSES 5 OF 8 EVENTS. THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED PURITAN "STERILE FOAM TIPPED APPLICATOR" REF 25-1506 1PF 100. THE NASAL AND THROAT SWAB WAS USED PER THE PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING WAS PERFORMED. TESTING RESULTS WERE NEGATIVE. CONFIRMATION TESTING WAS PERFORMED. (CT VALUES NOT PROVIDED) THE CUSTOMER REPORTED THAT DUE TO AN ACUTE PROBLEM THE PATIENTS WHO TESTED POSITIVE HAD TO BE ADMITTED AS SUSPECTED CASES IN SINGLE ROOMS UNTIL THE RESULT OF THE PCR TEST ARE AVAILABLE. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. HANDLE SAMPLES ACCORDING TO STANDARD LABORATORY PRACTICES. CLEAN INSTRUMENTS AND SURROUNDING SURFACES ACCORDING TO INSTRUCTIONS PROVIDED IN THE CLEANING SECTION OF THE INSTRUMENT USER MANUAL. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537489 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1009983 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization