BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11638739 · Received April 8, 2021

    Report

    Report Number
    1221359-2021-00925
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 8, 2021
    Report Date
    July 21, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M140445 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 (B)(4) / LOT M140445 AND TEST BASE PART NUMBER (B)(4) / LOT M140445. 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 M140445 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING ROUTINE PATIENT TESTING, THERE WAS A FALSE POSITIVE RESULT WITH ID NOW COVID 19 ASSAY USING A DIRECT NASOPHARYNGEAL SWAB (NIPRO SPONGE SWAB TYPES) ON (B)(6) 2021. REPEAT TESTING (SAME DAY) WITH A NEW NASOPHARYNGEAL SAMPLE GENERATED NEGATIVE RESULTS. PCR CONFIRMATION TESTING (SAME DAY) ON A NASOPHARYNGEAL SAMPLE WITH THE FUJIREBIO COMPANY LUMIPULSE INSTRUMENT ALSO GENERATED NEGATIVE RESULTS. PER THE CUSTOMER, THE PATIENT WAS NOT SYMPTOMATIC AND WAS PLANNING TO START REHABILITATION AFTER TRANSFERRING TO THE HOSPITAL, BUT THE START OF REHABILITATION WAS DELAYED DUE TO CLOSE EXAMINATION AND MAY HAVE CAUSED WEAKNESS IN THE PATIENT; HOWEVER, THERE IS NO SERIOUS EFFECT FOR THIS EVENT. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA. PER THE ID NOW COVID-19 PRODUCT INSERT, PRECAUTIONS INCLUDE: 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. REFER TO SECTION 1.6, MAINTENANCE & CLEANING, FOR FURTHER INFORMATION. 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
    536043 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH M140445 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other