BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3073647 · Received April 23, 2013

    Report

    Report Number
    2032227-2013-01492
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    THE CUSTOMER'S MOTHER REPORTED THAT THE INSULIN PUMP DELIVERED INSULIN THAT SHE DID NOT PROGRAM. THE MOTHER STATED THAT THE BLOCK FEATURE WAS NOT TURNED ON AT THE TIME AND SHE WANTED TO LOWER THE MAXIMUM BOLUS AMOUNT FROM 10 TO 3, JUST IN CASE SOMETHING LIKE THIS EVER HAPPENS AGAIN. ASSISTED THE MOTHER WITH THE BOLUS MAXIMUM SETTING. NOTHING FURTHER WAS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174340 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR