BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM

    MDR report key: 476295 · Received July 21, 2003

    Report

    Report Number
    MW4003537
    Event Type
    Malfunction
    Date Received
    July 21, 2003
    Date of Event
    June 9, 2003
    Report Date
    June 16, 2003
    Manufacturer
    MEDTRONIC MINIMED INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IN 2003, MOTHER WOKE PT UP TO PERFORM DIABETIC BLOOD TEST AND HAD RESULT OF 547. MOTHER THEN NOTICED THAT PUMP MACHINE THAT PT IS ATTACHED TO 24HRS A DAY WAS NOT OPERATING AND THEREFORE PT DID NOT RECEIVE INSULIN THROUGHOUT THE NIGHT. CALLED PHYSICIAN AND RECEIVED INSTRUCTIONS -SHOTS EVERY 2 HOURS OF INSULIN FROM 2.8 TO 5 UNITS ON TOP OF BOLUS DOSE (BASED ON CARBOHYDRATES). PT STAYED HOME FROM SCHOOL SO KETONES COULD READJUST. THIS IS THE THIRD PUMP THEY HAVE HAD SINCE NOVEMBER 2002, ALL HAVE MALFUNCTIONED IN SOME WAY. MINIMED ONLY SENDS REFURBISHED PUMPS. PEDIATRICIAN HAS SAID THAT HE WILL NEVER REFER PTS TO MINIMED AGAIN DUE TO THE NUMBER OF PROBLEMS HE HAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN PUMP LZG MEDTRONIC MINIMED INC. * 031599-6B

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR