BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4130238 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24496
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO 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 AN ERROR. THE DEVICE WOULD NOT ALLOW THE CUSTOMER TO COMPLETE THE PRIMING PROCESS. THE CUSTOMER'S BLOOD GLUCOSE WAS 216 MG/DL. THE DRIVE SUPPORT CAP WAS RECESSED. THE CUSTOMER STATED THAT THE DEVICE HAD NOT BEEN DROPPED. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578919 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR