BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3841697 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-85236
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE CUSTOMER CALLED TO REPORT THAT SHE HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE SYMPTOMS OF HIGH BLOOD GLUCOSE LEVELS THAT SHE EXPERIENCED WERE NAUSEA, VOMITING, AND DIZZINESS. THE CUSTOMER'S SYMPTOMS MADE HER TO GO TO THE URGENT CARE THAT SAME MORNING AND FROM THERE SHE WAS TAKEN TO THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE LEVELS REACHED 502 MG/DL AT THE TIME OF HER VISIT. THE CUSTOMER ALSO MENTIONED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS LAST JULY BUT SPECIFIC DETAILS ABOUT THE INCIDENT ARE UNKNOWN. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319490 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization