BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3943028 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87661
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 REPORTED THAT HIS INSULIN PUMP IS GIVING LOW BLOOD GLUCOSE ALERTS ALL THE TIME AND IT IS VERY ANNOYING. THE SENSOR WILL KEEP SENDING READINGS TO CUSTOMER'S DEVICE, TRIGGERING THE LOW ALERTS. THE LOW BLOOD GLUCOSE REMINDER IS NOT SET. CUSTOMER CANNOT HEAR THE DEVICE BEEP, BUT HE FEELS IT WHEN IT VIBRATES. HE WAS ADVISED TO CHANGE ALERTS TO VIBRATE. RIGHT NOW IT IS COMBINATION OF BEEPING AND VIBRATING. CUSTOMER ALSO REPORTED THAT HE HAS RED MARKS ALL OVER HIS STOMACH AREA FROM THE ENLITE SENSOR OVERTAPE. CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419321 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR