BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3034004 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-92302
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION, BASIC OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST DUE TO PRIME/FILL ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE FOR THE PAST THREE WEEKS, AND SHE BELIEVES THE INSULIN PUMP WAS NOT FUNCTIONING. THE CUSTOMER EXPERIENCED NAUSEA, MIGRAINES, EXCESSIVE URINATION, THIRST, LOSS OF APPETITE, AND FATIGUE. THE CALLER STATED THAT SHE HAD AN URGENT CARE VISIT DUE TO HER HIGH BLOOD GLUCOSE OVER 350MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS NORMAL. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. THE CUSTOMER MENTIONED THAT THE CANNULA WAS OCCLUDED. THE CUSTOMER REQUESTED HAVING THE DEVICE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135665 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization