BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170393 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37785
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT SHE WAS HAVING TROUBLE DELIVERING INSULIN. SHE STATED THERE WAS NO ALARMS BUT THE BLOOD GLUCOSE WAS HIGH. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 493 MG/DL. CUSTOMER TREATED WITH BOLUS. ADVISED CUSTOMER THE 2 HIGH BLOOD GLUCOSE. ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTION. CUSTOMER STATED THAT SHE GOT OUT OF THE HOSPITAL AND SHE'S HAVING TO SWITCH FINGERS TO DO THE FILL TUBING. CUSTOMER STATED THAT HOSPITALIZATION WAS NOT DUE TO DIABETES. THE CUSTOMER DOES NOT HAVE THE TUBING CLAMP. ADVISED WILL TUBING CLAMP AND TO REPORT BACK TO CONTINUE THE TROUBLESHOOT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651749 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 62 YR