BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3901755 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86178
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 21, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 SOMETHING MUST BE WRONG WITH THE INSULIN PUMP. PHYSICIAN THINKS THAT THE INSULIN PUMP IS NOT WORKING. CUSTOMER IS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER IS VOMITING AND HIGH KETONES. THE BLOOD GLUCOSE READING WAS 590 MG/DL; THE BLOOD GLUCOSE DECREASED TO 400 MG/DL AT THE HOSPITAL. CUSTOMER HAS BEEN SICK FOR FOUR DAYS. CUSTOMER ALSO SICK WITH FLU. DIAGNOSED DIABETES KETOACIDOSIS WITH SEVERE DEHYDRATION. HOSPITAL TREATED WITH IV DRIP. DURING TROUBLESHOOTING, THE HIGH PRESSURE TEST FAILED TWICE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379019 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization