BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3812660 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-84648
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2011
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CUSTOMER WAS NOT GETTING ANY INSULIN AND HIS BLOOD GLUCOSE WAS IN THE 400'S MG/DL AS WELL THE KETONES WERE OFF THE CHARTS. THE MOTHER STATED THAT SHE PULLED THE INFUSION SET AND NOTICED THAT IT WAS BENT IN THREE DIFFERENT PLACES AS WELL IT WAS SMASHED. THE CALLER STATED THAT THE CUSTOMER DID NOT GET ANY WARNINGS THAT HE WAS NOT RECEIVING INSULIN. THE CALLER ALSO STATED THAT SHE CAN NOT GET THE SENSORS TO BE ACCURATE AND THE CUSTOMER WAS GETTING WEAK AND LOST SENSOR ALARMS. THE MOTHER EVENTUALLY SHUT THE SENSORS OFF BECAUSE THE THRESH SUSPEND KEPT GOING OFF. THE CUSTOMER WAS WEARING THE SENSORS ON HIS BOTTOM PER DOCTOR'S SUGGESTION. THE MOTHER ALSO REPORTED HAVING ISSUES WITH TAPE NOT STICKING ON THE CUSTOMER SINCE HE IS A TODDLER AND THE SENSORS STAYED ONLY FOR A DAY BECAUSE THE TAPE CAME OFF. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290934 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO