BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2990713 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-91622
    Date Received
    March 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

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

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 230MG/DL. THE NURSE STATED THAT THE CUSTOMER EXPERIENCED NAUSEA, VOMITING, AND DIARRHEA AFTER DINNER. IT WAS STATED THAT THE CUSTOMER TURNED OFF THE INSULIN PUMP PRIOR TO HIS ADMISSION. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE ALARMED AFTER BATTERY CHANGE. ASSISTED THE NURSE TO CLEAR THE ALARM AND TO PROGRAM THE TIME AND DATE. IT WAS MENTIONED THAT THE CUSTOMER DROPPED THE DEVICE ON A CARPET FLOOR, AND THE INSULIN PUMP WAS CRACKED FROM THE BATTERY COMPARTMENT DOWN AND SIDEWAYS OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94365 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization