BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3974054 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88823
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ALERTS ON HIS INSULIN PUMP KEEP HIM UP AT NIGHT AND THAT THE PREDICTIONS ARE INCORRECT. CUSTOMER STATED THAT THE INSULIN PUMP WILL ALERT THAT HE HAS LOW BLOOD GLUCOSE WHEN IT IS ACTUALLY HIGH, AND WHEN HE ATTEMPTS TO DELIVER A BOLUS THE INSULIN PUMP WILL AUTOMATICALLY SUSPEND IT. HE STATED THAT HE TREATED WITH MANUAL INJECTION. THE BLOOD GLUCOSE READING WAS 416 MG/DL. CUSTOMER ALSO REPORTED RECEIVING ALARMS FOR NO DELIVERY. HE WAS ASSISTED IN PERFORMING A FIXED PRIME AND STATED THAT INSULIN DID EXIT FROM THE TUBING. CUSTOMER REMOVED THE INFUSION SET AND STATED THAT THE CANNULA WAS BENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450815 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR