BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3970017 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88383
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED EXCESSIVELY AND REPETITIVELY. THE CUSTOMER WAS UNABLE TO GET THE DEVICE TO COOPERATE. THE BLOOD GLUCOSE READING WAS UNKNOWN AND IS BEING INVESTIGATED. THE CUSTOMER STATED THAT THE ALARM PROMPTED TO ENTER THE METER BLOOD GLUCOSE NOW AND ALERTED LOW BLOOD GLUCOSE LEVELS. HE CLEARED THE ALARMS BUT THEN THEY WOULD REOCCUR RIGHT AWAY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446652 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR