BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933457 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03866
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    CUSTOMER REPORTED A HIGH BLOOD GLUCOSE EVENT. THE BLOOD GLUCOSE READING WAS 600 MG/DL. CUSTOMER EXPERIENCED A HEADACHE AS A SYMPTOM OF THE HIGH BLOOD GLUCOSE. SHE HAD NOT TREATED HERSELF YET AT THE TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED TO FIND THE CAUSE OF THE ISSUE. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL AND RECESSED. SHE WAS ASSISTED IN REMOVING AIR BUBBLES FROM THE TUBING AND REWINDING THE INSULIN PUMP. CUSTOMER WAS ABLE TO PRIME THE INSULIN PUMP AND RAN A HIGH PRESSURE TEST, WHICH PASSED. SHE TREATED WITH A BOLUS AT THIS TIME BEFORE CONTINUING TO TROUBLESHOOT. CUSTOMER REMOVED THE INFUSION SET FROM HER BODY AND THE CANNULA WAS NOT BENT OR OCCLUDED. SHE STATED THAT THE INSERTION SITE WAS SORE. SHE WAS ADVISED TO CHECK THE INSULIN VIAL AND FOUND THAT THE INSULIN WAS CLEAR AND NOT EXPIRED. SHE STATED SHE WAS FEELING DIZZY AND WAS ADVISED TO CONTACT HER DOCTOR IF THE BLOOD GLUCOSE DID NOT COME DOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410916 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR