BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8250953 · Received January 15, 2019

    Report

    Report Number
    3013756811-2019-02073
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    October 1, 2018
    Report Date
    January 15, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, AN ADDITIONAL RESULT WAS IDENTIFIED (170) AND A DIFFERENT ISSUE WAS IDENTIFIED (4116).

    Additional Manufacturer Narrative · 1

    PUMP SERIAL NUMBERS: (B)(4). CARTRIDGE LOT NUMBER: M021850. USER OVERFILLING THE CARTRIDGE BAG CAUSING A PRESSURE LEAK.

    Description of Event or Problem · 1

    QUARTERLY SUMMARY REPORT FOR ALLEGED ALTITUDE ALARMS: IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED WITHIN LABELED ALTITUDE RANGE. THE ALARM WAS ULTIMATELY CLEARED OR USER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY TO ADDRESS THE ISSUE. THERE WAS NO ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41214 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1