BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722

    MDR report key: 8234022 · Received January 10, 2019

    Report

    Report Number
    3004209178-2019-42988
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    August 1, 2018
    Report Date
    February 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IN THE STUDY, "SAFETY OF THE BATTERIES AND POWER UNITS USED IN INSULIN PUMPS: A PILOT CROSS-SECTIONAL STUDY BY THE ASSOCIATION FOR THE STUDY OF INNOVATIVE DIABETES TREATMENT IN (B)(6)", THERE WAS AN INSPECTION OF SAFETY OF THE BATTERIES AND POWER UNITS USED IN INSULIN PUMPS IN (B)(6). MATERIALS AND METHODS: A SELF-ADMINISTERED QUESTIONNAIRE WAS SENT TO THE 201 MEMBERS OF THE ASSOCIATION FOR INNOVATIVE DIABETES TREATMENT IN (B)(6). AS OF (B)(6) 2016, MINIMED 620G AND PARADIGM 722 (MEDTRONIC MINIMED, INC., (B)(4)) WERE MAINLY USED IN (B)(6), AND A SMALL NUMBER OF TOP-8100 AND TOP-8200 (TOP CORPORATION, (B)(6)) WERE USED (TABLE S1). RESULTS: A TOTAL OF 56 MEMBERS RESPONDED, AND AMONG THE 1,499 ACTIVE DEVICES, 66 HAD EPISODES OF TROUBLE RELATED TO THE BATTERIES AND POWER UNITS. THE RATIO OF REPORTED TROUBLES TO THE NUMBER OF INSULIN PUMPS WAS SIGNIFICANTLY HIGHER IN INSULIN PUMPS WITH A CONTINUOUS GLUCOSE MONITORING SENSOR COMPARED WITH INSULIN PUMPS WITHOUT A CONTINUOUS GLUCOSE MONITORING SENSOR (ODDS RATIO 2.82, P < 0.05). THE CAUSE AND THE CONSEQUENCES VARIED. THE BRANDS OF THE BATTERIES VARIED; ALKALINE BATTERIES PURCHASED AT DRUG STORES AND OTHER SHOPS ACCOUNTED FOR 19.7%. TERMINATION OF BATTERY LIFE WITHIN 72 H OF USE WAS REPORTED MOST FREQUENTLY (50.0%), SUSPENSION OF THE INSULIN PUMP (21.2%) AND LEAKAGE OF THE BATTERY FLUID (4.5%) FOLLOWED. A TOTAL OF 53.2% OF THE REPORTED INSULIN PUMPS NEEDED TO BE REPLACED, AND 37.1% OF THEM RECOVERED AFTER REPLACEMENT OF THE BATTERY. A TOTAL OF 24 (B)(6) MEMBERS REPORTED TROUBLES OCCURRING IN THE BATTERIES AND POWER UNITS, AND THE REPORTS ON MINIMED 620G WITH CGM SENSOR WERE MOST COMMON. A POWER ERROR MESSAGE GENERATED BY THE MINIMED 620G WITH A CGM SENSOR WAS REPORTED MOST FREQUENTLY. NO SPECIFIC DEVICES WERE RETURNED FOR ANALYSIS AS A RESULT OF THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29391 PUMP MMT-722 PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722

    Patients

    Seq Age Sex Outcome Treatment
    1