BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3841691 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-85234
    Event Type
    Death
    Date Received
    May 30, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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.

    Description of Event or Problem · 1

    THE CUSTOMER'S SPOUSE CALLED IN TO REPORT THAT HER HUSBAND HAD PASSED AWAY. SHE STATED THAT HER HUSBAND DIED FROM CEREBRAL ARTERY STROKE, CARDIAC ARREST, LOW BLOOD PRESSURE, AND DIABETES KETOACIDOSIS. SHE ALSO REPORTS THAT HER HUSBAND WAS IN THE INTENSIVE CARE UNIT AT THE HOSPITAL FOR FIVE DAYS PRIOR TO HIS DEATH. THE SIGNIFICANT EVENTS THAT LEAD UP TO THE CUSTOMER BEING ADMITTED TO THE HOSPITAL WAS THAT HE WAS HAVING SEIZURES AND VOMITTING. THE CUSTOMER'S BLOOD GLUCOSE IS UNKNOWN AT THE TIME OF HIS DEATH. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319474 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death