BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2212847 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82155
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN WAS SQUIRTING OUT DURING PRIME. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT INSULIN WAS DRIPPING AFTER THE MOTOR STOPPED AND THE INSULIN PUMP ALARMED MOTOR ERROR. REQUESTED TO CHANGE THE INFUSION SET AND RESTARTED THE PRIMING PROCESS. THE CUSTOMER STATED THAT INSULIN DID NOT COME OUT AFTER MOTOR STOPPED AND THE NUMBERS WERE RAMPING. RAN A DISPLACEMENT TEST AND THE INSULIN PUMP FAILED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR QUICK-SET, 23, PARADIGM, 9MM CATHETER| UNOMEDICAL INFUSION SET, MMT-397