BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2234070 · Received August 29, 2011

    Report

    Report Number
    3004209178-2011-82727
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 982MG/DL. IT WAS STATED THAT THE CUSTOMER ALSO HAD METABOLIC ACIDOSIS AND DEHYDRATION. IT WAS STATED THAT THE EVENTS LEADING TO HIS ADMISSION WAS VOMITING AND LEG CRAMPS. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST COUPLE OF WEEKS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 200MG/DL, AND HE HAS TREATED WITH THE INSULIN PUMP. THE TIME AND DATE ON THE INSULIN PUMP WERE CORRECT. REVIEWED THE PROGRAMMING AND THE ALARM HISTORY REVEALED NO DELIVERY AND LOW BATTERY ALARMS. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. THE WIFE REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization 23, PARADIGM, 9MM CATHETER| UNOMEDICAL INFUSION SET: MMT-397, QUICK-SET