BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2232431 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-82715
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED AND THE INSULIN PUMP WAS NOT FUNCTIONING. THE CALLED STATED THAT THE BUTTONS WERE UNRESPONSIVE AND RECOMMENDED HAVING THE INSULIN PUMP REPLACED. THE CALLED DECLINED TO TROUBLESHOOT THE INSULIN PUMP. IT WAS STATED THAT WHEN THE CUSTOMER TRIES TO BOLUS, IT GOES TO 0.0 UNITS AND DID NOT ALLOW HER TO SET THE BOLUS. IT WAS STATED THAT THE CUSTOMER TREATED HER BLOOD GLUCOSE OF 324 MG/DL PRIOR CALLING. NO FURTHER INFO 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-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization