BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3892334 · Received June 24, 2014

    Report

    Report Number
    2032227-2014-03323
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED AND LOOSE DRIVE SUPPORT DISK. NO PRIME ALARM. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING AN ALARM ON THE INSULIN PUMP WHICH DID NOT ALLOW THEM TO PRIME THE DEVICE. THE BLOOD GLUCOSE WAS 105 MG/DL. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THEY DID NOT PRESS THE CAP WHILE THEY WERE CONNECTED. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE INSULIN PUMP AND NEEDS TO BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367946 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR