BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5312489 · Received December 18, 2015

    Report

    Report Number
    2032227-2015-76327
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Date of Event
    December 6, 2015
    Report Date
    December 6, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 BATTERY OUT LIMIT FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 12 MMOL/L. THE CUSTOMER STATED THAT THE PUMP ALARMED BATTERY OUT LIMIT DURING NORMAL USE. THE CUSTOMER STATED THAT THE PUMP DID NOT STOP ALARMING BATTERY OUT LIMIT EVEN THOUGH ALARMS WERE DELETED. THE CUSTOMER STATED THAT THE PUMP STARTED COUNTING TILL 6 AND COULD NOT BE USED ANYMORE. THE CUSTOMER HAS AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER AND WILL APPLY FOR A NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838347 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1