BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN PUMP

    MDR report key: 8290964 · Received January 30, 2019

    Report

    Report Number
    3004209178-2019-49363
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    December 1, 2018
    Report Date
    January 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    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 JAPAN", THE AUTHORS INVESTIGATED THE SAFETY OF THE BATTERIES AND POWER UNITS USED IN INSULIN PUMPS IN JAPAN. A SELF-ADMINISTERED QUESTIONNAIRE WAS SENT TO THE 201 MEMBERS OF THE ASSOCIATION FOR INNOVATIVE DIABETES TREATMENT IN JAPAN. 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. AS OF (B)(6) 2016, MINIMED 620G, PARADIGM 722 AND PARADIGM 712 (B)(4) WERE MAINLY USED IN (B)(6), AND A SMALL NUMBER OF <NAME OMITTED> AND <NAME OMITTED> WERE USED. JUST 14.3% OF THE RESPONDENTS SUPPLIED THE BATTERIES FOR INSULIN PUMPS TO PATIENTS. AMONG THEM, 12.5% PURCHASED THE BATTERIES AT A MEDICAL INSTITUTION, AND 87.5% WERE PROVIDED BATTERIES BY THE SALES REPRESENTATIVES INVOLVED IN THE LEASING CONTRACT OF THE INSULIN PUMPS. NUMEROUS INSTANCES OF POWER ERROR ALARMS WERE REPORTED AS WELL. NO PRODUCTS WERE RETURNED FOR ANALYSIS AS A RESULT OF THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84348 PARADIGM INSULIN PUMP PUMP, INFUSION, INSULIN LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712

    Patients

    Seq Age Sex Outcome Treatment
    1