BEUDAMED
    FDA Adverse Event Other Summary report: N

    TENDER II

    MDR report key: 745988 · Received July 14, 2006

    Report

    Report Number
    8021545-2006-00001
    Event Type
    Other
    Date Received
    July 14, 2006
    Date of Event
    September 9, 2005
    Report Date
    June 14, 2006
    Manufacturer
    UNOMEDICAL INFUSION DEVICES A/S
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL TESTING: UNOMEDICAL'S QUALITY DEPARTMENT HAS PERFORMED A VISUAL TEST, A FLOW TEST AND A TEST FOR LEAKAGE OF THE RETURNED USED SAMPLE AND FOUND THE TUBING IS NEARLY TORN ABOUT 8 CM FROM WHERE THE TUBING CONNECTOR IS ATTACHED, FOR WHICH REASON THE TUBING IS LEAKING. CLAMP MARKS HAVE BEEN IDENTIFIED ON BOTH SIDES OF THE CUT ON THE TUBING, WHICH INDICATES USE OF A CLAMP AS A WAY OF STOPPING THE INSULIN FLOW - A MANEUVER WHICH IS STRONGLY ADVISED AGAINST BY THE MANUFACTURER. SINCE THE LOT NUMBER OF THE SET IS NOT AVAILABLE, BACKTRACKING THE LOT NUMBER FOR REVIEW OF THE HISTORY RECORDS OF THE LOT AS WELL AS TESTING THE RETAINED SAMPLES CANNOT BE PERFORMED. UNOMEDICAL ARE CONTINUOUSLY TRYING TO PROCURE INFORMATION ABOUT THE LOT NUMBER INVOLVED AND ADDITIONAL TESTING WILL OF COURSE BE PERFORMED IF THE LOT NUMBER IS MADE AVAILABLE, WHEREUPON AN APPROPRIATE FOLLOW UP REPORT WILL BE SUBMITTED. THE USE OF THE DEVICE: PATIENT UNDER CONTINUOUS INSULIN INFUSION THERAPY (CIIT) ARE REQUIRED TO CONTINUALLY ASSESS THE IMPACT OF SOME FACTORS ON THEIR BLOOD GLUCOSE LEVEL. SUCH FACTORS ARE CALORIE INTAKE, ACTIVITY LEVELS AND OTHER MEDICAL CONDITIONS AND/OR TREATMENTS. THE THERAPY ALSO REQUIRES THAT THE PATIENTS PERIODICALLY ARE SELF-TESTING THEIR ACTUAL BLOOD LEVELS. IN CASE OF HIGH BLOOD GLUCOSE LEVEL, THE PATIENT IS INSTRUCTED TO USE SUPPLEMENTAL INFUSION BY AN ALTERNATIVE METHOD AND/OR REPLACE THE INSULIN INFUSION SET. IF THIS DOES NOT SOLVE THE PROBLEM, THEN THE PATIENT IS INSTRUCTED TO ADMINISTER INSULIN BY INJECTION TO RESTORE THE BLOOD GLUCOSE CONTENT TO AN ACCEPTABLE LEVEL. IN CASE OF FAILURE TO MONITOR THE BLOOD GLUCOSE LEVELS AND/OR ADJUST THE INSULIN AMOUNT APPROPRIATELY, THE PATIENT CAN EXPERIENCE CONDITIONS SUCH AS DIABETIC KETOACIDOSIS (DKA), EXTREME HYPERGLYCEMIA OR EVEN INSULIN SHOCK. PATIENTS EXPERIENCING THESE CONDITIONS WILL REQUIRE HOSPITALIZATION AND MEDICAL INTERVENTION TO PREVENT SERIOUS MEDICAL CONDITIONS INCLUDING DEATH. CONCLUSIONS: AT PRESENT UNOMEDICAL INFUSION DEVICES HAVE NOT BEEN INFORMED ABOUT THE DETAILS REGARDING THIS INCIDENT. THE PLACE AND CAUSE OF DEATH IS UNKNOWN, BUT WE ARE OF COURSE CONTINUALLY ATTEMPTING TO PROVIDE THE LACKING INFORMATION FROM THE DISTRIBUTOR DISETRONIC ROCHE. THE DISCOVERED PRESSURE MARKS RENDERS IT PROBABLE THAT THE CUT HAS BEEN CAUSED BY THE END-USER'S HANDLING OF THE INFUSION SET, AS A WAY OF STOPPING THE INSULIN FLOW. OUR PRELIMINARY INVESTIGATIONS DOES NOT SUGGEST THAT THE PRESSURE MARKS COULD HAVE BEEN APPLIED DURING THE PRODUCTION PROCESS. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED IN WHICH WE THOROUGHLY WILL GO THROUGH THE PRODUCTION PROCESS. WE WILL OF COURSE SUBMIT THE RESULTS WHEN OUR INVESTIGATIONS HAVE BEEN PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT WAS FOUND DEAD WEARING AN INFUSION SET. ACCORDING TO THE DISTRIBUTOR DISETRONIC ROCHE, THE POLICE HAVE INVESTIGATED THE INCIDENT AND HAVE FOUND NO ASSOCIATION BETWEEN THE DEATH AND THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDER II SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL INFUSION DEVICES A/S 04360893001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other INSULIN| INSULIN INFUSION PUMP