BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2140435 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-81840
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY WHILE BEING AT THE DOCTOR'S OFFICE. IT WAS STATED THAT THE ALARM WAS UNABLE TO CLEAR AND THE CUSTOMER WAS SENT TO THE HOSPITAL. THE MOTHER STATED THAT THE CUSTOMER WAS TREATED WITH HER BACK UP PLAN. HAD MOTHER DISCONNECT THE TUBING FROM THE CHILD TO REWIND AND PRIME, BUT THE NO DELIVERY ALARM TRIGGERED WHILE PRIMING. ASKED MOTHER TO CHANGE THE INFUSION SET AND RESERVOIR TO REWIND AND PRIME ONCE AGAIN AND THE INSULIN PUMP ALARMED NO DELIVERY. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WERE DROPPING FROM 600MG/DL. IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN UNTIL THE REPLACEMENT OF THE INSULIN PUMP ARRIVES. 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-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization