BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4103805 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26552
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING AN INFUSION SET AND RESERVOIR CHANGE. THE CUSTOMERS' BLOOD GLUCOSE WAS 175 MG/DL. THE CUSTOMER STATED THAT THE NO DELIVERY ALARM HAD BEEN RESOLVED BY A COMPLETE SET CHANGE OF RESERVOIR AND INFUSION SET. SINCE THE REPORTED ISSUE WAS A PAST EVEN NO TROUBLESHOOTING WAS PERFORMED AND THE CAUSE OF THE ALARM COULD NOT BE DETERMINED. THE CUSTOMER WANTED TO RETURNER THE RESERVOIR AND THE INFUSION SET FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584273 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A H8852781

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR