BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARDIGM SILHOUETTE

    MDR report key: 407742 · Received July 25, 2002

    Report

    Report Number
    MW1025682
    Event Type
    Other
    Date Received
    July 25, 2002
    Date of Event
    July 14, 2002
    Report Date
    July 25, 2002
    Manufacturer
    MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PARADIGM INSULIN PUMP PT EXPERIENCED UNEXPECTEDLY HIGH BLOOD GLUCOSE (BG) LEVELS FOR THREE DAYS. BG RETURNED TO NORMAL RANGE AFTER HUMALOG INSULIN BY SYRINGE. SMALL TO MODERATE URINE KETONES WERE NOTED THE SECOND AND THIRD DAY. PT LOST 4 LBS DURING WEEK ACCORDING TO HOME SCALE. UPON REMOVAL OF SILHOUETTE INFUSION SETS AFTER EACH EPISODE OF HIGH BG, IT WAS NOTED THAT SUBQ CATHETER WAS KINKED AT RIGHT ANGLE APPARENTLY BLOCKING INSULIN FLOW. SETS HAD BEEN PLACED USING SIL-SERTER DEVICE. PARADIGM PUMP DID NOT ALARM TO INDICATE NO INSULIN DELIVERY DURING ANY EPISODE. PT WAS AWAY FROM HOME AND DEPLETED SUPPLY OF INFUSION SETS DUE TO KINKING. PARENT CONTACTED MEDTRONIC CLINICAL SUPPORT ON 7/2002 WHO OFFERED TO SEND NEW INFUSION SETS FOR NEXT DAY DELIVERY. PT WAS MAINTAINED ON FREQUENT DOSES OF SHORT ACTING INSULIN THROUGH SYRINGE BUT BG'S WERE ERRATIC DUE TO LACK OF BASAL CONTROL. NEW SETS FAILED TO ARRIVE AS PROMISED. INITIATED LONG ACTING INSULIN AND BG'S MODERATED. PROMISED INFUSION SETS ARRIVED ON 2 DAYS LATER BUT WERE INCOMPATIBLE WITH PARADIGM PUMP. MEDTRONIC CLINICAL SUPPORT DID NOT REQUEST RETURN OF PUMP OR FAILED SILHOUETTE SETS AND DID NOT REQUEST LOT NUMBER OR ANY OTHER INFO CONSISTENT WITH STANDARD COMPLAINT REPORTING PRACTICES IN THIS INSTANCE OR PREVIOUS OCCURRENCES OF THIS FAILURE. ON 7/20/02 PARENT OF PT CONTACTED MEDTRONIC/MINIMED CLINICAL SUPPORT SUPV AND INDICATED CONCERN OVER PT INJURY AND REQUESTED THAT THEIR FIELD ASSURANCE DEPT BE INFORMED AND CALL PARENT TO COLLECT COMPLAINT DATA. AS OF THIS WRITING FIELD ASSURANCE PERSONNEL HAVE NOT CONTACTED PARENT. AS MEDTRONIC/MINIMED CLINICAL SUPPORT HAS ATTEMPTED TO "TROUBLE SHOOT" PROBLEM IN INSTANCES PRIOR TO EVENT AND DID NOT OBTAIN COMPLAINT DATA, RPTR FEELS FAILURE MAY BE UNDER ACKNOWLEDGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARDIGM SILHOUETTE INSULIN INFUSION SET FPA MINIMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other 2) SIL-SERTER AUTOMATED INFUSION SET INSERTION| 1) PARADIGM INSULIN PUMP,| DEVICE.