BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11406694 · Received March 3, 2021

    Report

    Report Number
    1221359-2021-00611
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    January 29, 2021
    Report Date
    April 2, 2021
    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
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MANUFACTURER REPORT: 1221359-2021-00610. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1013538 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 1013538, TEST BASE PART NUMBER 190-430 / LOT 1013538. 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 1013538 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    BASED ON MEDICAL OPINION, IT WAS DETERMINED THIS EVENT IS REPORTABLE PER (B)(4) TO THE POTENTIAL OF INDIRECT HARM, INCLUDING SERIOUS INJURY TO THE PATIENT, AS A RESULT OF THE SURGERY BEING CANCELLED DUE TO THE PHYSICIAN'S FALSE POSITIVE TEST RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT 2 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A NASOPHARYNGEAL DIRECT TESTED SWAB. IT IS UNKNOWN IF REPEAT TESTING WAS PERFORMED. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 AT TWO DIFFERENT LOCATIONS WITH NASOPHARYNGEAL AND THROAT SWABS. THE FIRST CONFIRMATION TEST PERFORMED WITH ALLPLEX, SEEGENE PCR PLATFORM GENERATED NEGATIVE RESULTS; CT VALUES NOT PROVIDED. THE SECOND CONFIRMATION TEST USING AN UNKNOWN PCR PLATFORM ALSO GENERATED NEGATIVE RESULTS; CT VALUES NOT PROVIDED. THE CUSTOMER STATED THE PATIENT WAS A HOSPITAL WORKER WHO WAS PRESENT TO ASSIST WITH A SCHEDULED PROCEDURE WHICH WAS CANCELLED DUE TO THE FALSE POSITIVE RESULTS (ADDITIONAL INFORMATION REQUESTED) . THE CUSTOMER STATED THE PATIENT NEEDED TO QUARANTINE DUE TO THE TEST RESULTS AND THE RESULTS CAUSED PANIC. THE PATIENT WAS REQUIRED TO QUARANTINE FOR SEVEN TO TEN DAYS AS A PRECAUTION TO ENSURE HE DID NOT HAVE COVID-19. NO PATIENT HARM WAS REPORTED. 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
    302960 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013538 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other