BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPILLARY BLOOD SPECIMEN COLLECTION SUPPLEMENTAL PACK

    MDR report key: 19269761 · Received May 8, 2024

    Report

    Report Number
    3011854503-2024-00001
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    September 27, 2023
    Report Date
    May 3, 2024
    Manufacturer
    BIODESIX INC
    Product Code
    PQD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 03MAY2024, BIODESIX MET WITH THE MANUFACTURER OF THE DEVICE, TASSO INC., TO COMMUNICATE THE EVENT REGARDING THE USE OF THEIR MEDICAL DEVICE, THE TASSO+ DEVICE. THE MANUFACTURER CONFIRMED THAT THIS IS THE FIRST TIME LOGGING SUCH AN EVENT AS THEY HAVE NOT BEEN INFORMED OF THIS TYPE OF EVENT OCCURING PREVIOUSLY. TASSO WILL LOG AND CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    ON 28SEP2023 BIODESIX BECAME AWARE OF THE FOLLOWING EVENT: UPON A ROUTINE BLOOD SAMPLE COLLECTION USING THE TASSO, INC. TASSO+ DEVICE (LOT NUMBER: W0230562), AN FDA CLASS II LANCET, 510(K) CLEARED DEVICE INTENDED FOR OBTAINING MICROLITER CAPILLARY WHOLE BLOOD SAMPLES, THE PATIENT CONTINUED TO BLEED FOR 27 HOURS POST-DRAW. THE PATIENT WENT TO THE EMERGENCY ROOM, AND THE ER DOCTOR APPLIED 4 LAYERS OF SKIN GLUE TO THE DRAW SITE ON HER ARM WHICH STOPPED THE BLEEDING, MEDICAL INTERVENTION WAS TAKEN TO PRECLUDE PERMANENT DAMAGE TO THE PATIENT. THE TASSO+ DEVICE IS A COMPONENT OF THE BIODESIX CAPILLARY BLOOD SPECIMEN COLLECTION SUPPLEMENTAL PACK. UPON CONTACTING THE PATIENT FOR FURTHER INFORMATION ON 04OCT2023, THE PATIENT STATED THAT SHE IS "ABSOLUTELY FINE NOW" AND THAT SHE REQUIRED NO FURTHER MEDICAL TREATMENT AS A RESULT OF THIS EVENT. PATIENT ALSO UNSOLICITEDLY OFFERED TO SIGN A RELEASE FOR THE MEDICAL RECORDS AT THE EMERGENCY DEPARTMENT. INITIAL DOCUMENTATION OF THE EVENT DISPLAYED THAT THE GROUPS REVIEWING THE COMPLAINT DID NOT APPLY THE CRITERIA CORRECTLY, BUT THERE WAS AN INVESTIGATION AND RATIONALE AROUND THE DECISION NOT TO REPORT. DOCUMENTATION OF WHY THE EVENT WAS NOT REPORTABLE STATED THAT THE USE OF BLOOD THINNERS MEANT THE PATIENT WAS NOT IN THE INTENDED USE POPULATION FOR THE CAPILLARY BLOOD SPECIMEN COLLECTION SUPPLEMENTAL PACK. DURING THE RETROSPECTIVE REVIEW COMPLETED 01MAY2024 TO 03MAY2024, THE POST-MARKET COMPLIANCE TEAM LOOKED AT THE SAME FACTS THAT WERE AVAILABLE DURING THE INITIAL COMPLAINT INTAKE AND MADE THE DECISION TO ESCALATE TO THE CHIEF MEDICAL OFFICER AND SENIOR DIRECTOR OF MEDICAL AND SCIENTIFIC AFFAIRS. THE CHIEF MEDICAL OFFICER AND SR. DIRECTOR, MEDICAL AND SCIENTIFIC AFFAIRS EVALUATED THE ENTIRE COMPLAINT RECORD AND RECOMMENDED THIS BE REPORTED. WHILE THE PATIENT CONFIRMED THERE WAS NO FURTHER HARM NOR PERMANENT DAMAGE, THE TEAM CONSENSUS WAS TO REPORT THIS INCIDENT OUT OF AN ABUNDANCE OF CAUTION TO ENSURE ALL APPROPRIATE ACTION IS TAKEN. THE DEVICE WAS USED OUTSIDE OF THE INTENDED USE POPULATION ESTABLISHED BY BIODESIX BECAUSE THE PATIENT WAS ON BLOOD THINNERS WHICH COULD HAVE CAUSED THE DRAW SITE TO NOT STOP BLEEDING FOR A DAY. THE USE OF THE DEVICE DID FALL WITHIN THE INTENDED USE POPULATION AS ESTABLISHED BY TASSO, INC. AS THERE WERE NO CONTRAINDICATIONS FOR PATIENTS ON BLOOD THINNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123461 CAPILLARY BLOOD SPECIMEN COLLECTION SUPPLEMENTAL PACK BLOOD SPECIMEN COLLECTION KIT PQD BIODESIX INC 59 V3.0 11092023-02

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention PLAVIX.