BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2800726 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-90277
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO KETONES AND HIGH BLOOD GLUCOSE OVER 900MG/DL. THE CALLER STATED THAT HE WAS RECEIVING NO DELIVERY ALARMS. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN UNTIL THE REPLACEMENT OF THE INSULIN PUMP ARRIVES. THE CUSTOMER CALLED BACK AND STATED THAT HE IS NOT FEELING WELL. THE CALLER MENTIONED THAT HE BLACKED OUT EARLIER AND FELL. THE CALLER STATED THAT HE WAS THROWING UP AND HAD ISSUES WITH HIS KIDNEYS. THE CUSTOMER STATED THAT HE IS NOT SURE IF IT IS THE INSULIN PUMP, AND THEY COMING TO TAKE HIM TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization