BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMT-715 PARADIGM INSULIN PUMP

    MDR report key: 6583344 · Received May 22, 2017

    Report

    Report Number
    2032227-2017-20567
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    April 1, 2017
    Report Date
    May 22, 2017
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT DUE TO THE LIMITED SCOPE OF THE STUDY. RABBONE, I, ET AL. " INSULIN PUMP FAILURES IN (B)(4) CHILDREN WITH TYPE 1 DIABETES: RETROSPECTIVE 1-YEAR COHORT STUDY" DIABET. MED. 2017 34:5 (621-624).

    Description of Event or Problem · 1

    <P STYLE="MARGIN: 0IN 0IN 8PT;">IN A STUDY REGARDING INSULIN PUMP FAILURE AND/OR MALFUNCTION REQUIRING REPLACEMENT EVALUATED PUMP REPLACEMENT IN CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES USING INSULIN PUMP THERAPY. DATA WERE COLLECTED FOR PARTICIPANTS YOUNGER THAN 19 YEARS, STARTING INSULIN PUMP THERAPY BEFORE 31 DECEMBER 2013. IN TOTAL, 1574 OF 11 311 (13.9%) CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES WERE USING AN INSULIN PUMP: 29.2% PRODUCT A, 9.4% MEDTRONIC (B)(4) 715/515¿, 34.3% MEDTRONIC MINIMED VEO, 24.3% PRODUCT D AND 2.8% OTHER MODELS. 2013, 0.165 INSULIN PUMP REPLACEMENTS PER PATIENT YEAR(11.8% DUE TO PUMP FAILURE/MALFUNCTION AND 4.7% DUE TO ACCIDENTAL DAMAGE) WERE RECORDED. THE STUDY CONCLUDED THAT INSULIN PUMP FAILURE/MALFUNCTION AND CONSEQUENT REPLACEMENT ARE ALIGNED WITH RATES PREVIOUSLY REPORTED AND HIGHER IN MORE SOPHISTICATED PUMP MODELS.</P>.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362134 MMT-715 PARADIGM INSULIN PUMP PUMP, INFUSION, INSULIN LZG MEDTRONIC MINIMED MMT-715

    Patients

    Seq Age Sex Outcome Treatment
    1