BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2102639 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81554
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS NOT DELIVERING INSULIN. THE CUSTOMER'S MOTHER STATED THAT SHE DID A 3.0 UNIT BOLUS IN THE AIR AND DID NOT SEE ANY INSULIN EXIT THE TUBING. THE CUSTOMER'S MOTHER THEN STATED THAT THERE WERE NO ALARMS IN THE ALARM HISTORY. THE CUSTOMER'S MOTHER ALSO MENTIONED THAT THE CUSTOMER USES A QUICK-SET INFUSION SET. TROUBLESHOOTING WAS PERFORMED AND NO INSULIN CAME OUT THE TUBING DURING THE FIXED PRIME TEST. NOTHING FURTHER WAS REPORTED.

    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-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR UNOMEDICAL QUICK-SET INSULIN INFUSION SET| MODEL MMT-399