BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TDX/TDXFLX CANNABINOIDS REAGENT

    MDR report key: 777850 · Received November 8, 2006

    Report

    Report Number
    2623532-2006-00003
    Event Type
    Injury
    Date Received
    November 8, 2006
    Date of Event
    October 31, 2006
    Report Date
    October 31, 2006
    Manufacturer
    ABBOTT HEALTH PRODUCTS, INC.
    Product Code
    LDJ
    PMA / PMN Number
    k864751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALSO REFERENCE 510(K)#: K874646 (DELTA-9 REFORMULATION CALIBRATORS AND CONTROLS). WHY NOT CODE (H3): (A REVIEW OF THE COMPLAINT DOCUMENTATION IDENTIFIED THAT THE EVENT WAS CAUSED BY HUMAN ERROR AND DID NOT INVOLVE THE DEVICE NOR WAS CAUSED BY A FAILURE OF THE DEVICE). A REVIEW OF THE COMPLAINT DOCUMENTATION IDENTIFIED THAT THE EVENT OCCURRED WHEN THE OPERATOR PUSHED TOO HARD WHEN PIPETTING A CONTROL SAMPLE, WHICH PUNCTURED THE BOTTOM OF THE CONTROL BOTTLE AND IN TURN PUNCTURED THE OPERATOR'S FINGER. THE EVENT WAS NOT CAUSED BY A MALUFUNCTION OF THE DEVICE OR A PRODUCT PERFORMANCE ISSUE. THE EVENT WAS CAUSED BY USER ERROR. THIS EVENT IS ADDRESSED IN THE TDX/TDXFLX CANNABINOIDS PACKAGE INSERT (34-3966/R7), WARNINGS AND PRECAUTIONS FOR USERS SECTION AND IN THE X-SYSTEMS CANNABINOIDS CONTROL PACKAGE INSERT (34-39621/R10), PRECAUTIONS SECTION, WHERE DOCUMENTATION EMPHASIZES THAT SAMPLES AND REAGENTS SHOULD BE HANDLED WITH APPROPRIATE BIOSAFETY PRACTICES. THE INVESTGATION DEMONSTRATED THAT THE TDXFLX CANNABINOIDS ASSAY IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WHILE PIPETTING X-SYSTEMS CANNABINOIDS CONTROLS FROM THE POSITIVE CONTROL VIAL, SHE PUSHED SO HARD ON THE PIPETTE (ATTEMPTING TO TIGHTEN A LOOSE PIPETTE TIP TO THE PIPETTE BARREL) THAT THE PIPETTE TIP WENT THROUGH THE BOTTOM OF THE CONTROL VIAL AND PUNCTURED HER FINGER CAUSING IT TO BLEED. THE CUSTOMER WAS NOT WEARING GLOVES AT THE TIME OF THE EVENT. THE CUSTOMER WASHED AND RINSED THE WOUND FOR 10 MINUTES. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) DISCUSSED AND REFERENCED THE PRECAUTIONS LISTED IN THE PRODUCT'S PACKAGE INSERT. THE CUSTOMER CONSULTED WITH A PHYSICIAN AND WENT TO THE EMERGENCY DEPARTMENT WHERE SHE WAS ADMINISTERED A TETANUS SHOT. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDX/TDXFLX CANNABINOIDS REAGENT CANNABINOID TEST SYSTEM LDJ ABBOTT HEALTH PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention X-SYSTEMS CANNABINOIDS CONTROL LIST#: 9671-11| EXPIRY: 04/29/2007| LOT#: 40563Q100