BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3895479 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86134
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN; THE INFUSION SET WAS CHANGED. CUSTOMER EXPERIENCING HIGH BLOOD GLUCOSE. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CALLER STATED THAT LATER THAT NIGHT THE BLOOD GLUCOSE ROSE TO 440 MG/DL WITH KETONES. CUSTOMER TREATED WITH MANUAL INJECTION. THE BLOOD GLUCOSE READING DECREASED TO 247 MG/DL. THIS HIGH FOR THE EARLY MORNING. CALLER TREATED AGAIN WITH MANUAL INJECTION. CALLER HAD TAKEN DAUGHTER TO HOSPITAL BECAUSE OF VOMITING, KETONES AND LETHARGIC. CALLER STATED THAT THE INSULIN PUMP WAS NOT DELIVERING THE BASAL. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 200 MG/DL. HOSPITAL TREATED WITH IV FLUID. GIVEN MEDICATION FOR NAUSEA AND VOMITING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370374 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization