BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 5092767 · Received September 21, 2015

    Report

    Report Number
    2032227-2015-46645
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED OF A KEYPAD ANOMALY FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 150 MG/DL. THE CUSTOMER REPORTED KEYPAD ANOMALY DURING BOLUS SETTING. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENT LEADING TO THE ALARM. THE CUSTOMER WILL BE SENT A REPLACEMENT INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623223 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-715LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1