BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3895439 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86154
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. 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 STATED THAT THE INSULIN PUMP DID NOT ALARM WHEN THE RESERVOIR WAS EMPTY. CUSTOMER STATED THAT SHE PROGRAMMED A BOLUS AND THE INSULIN PUMP SHOWED A DELIVERED BOLUS, THE RESERVOIR WAS EMPTY. CUSTOMER WAS UNAWARE THAT SHE WAS OUT OF INSULIN. THE INSULIN PUMP USED TO ALARM WHEN THE RESERVOIR WAS EMPTY. THIS HAS HAPPENED NUMEROUS TIMES. ASSISTED CUSTOMER WITH SETTING THE LOW RESERVOIR ALARM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370505 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR