BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2962671 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-91068
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS DELIVERING MORE INSULIN THAN IT SHOULD DELIVER VIA BOLUS WIZARD. THE CUSTOMER'S BLOOD GLUCOSE WAS 3.2MMOL/L, AND THE CUSTOMER WAS GIVEN JELLYBEANS. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER WAS CONNECTED WHILE DOING A PRIME TEST. REVIEWED THE BOLUS OPTION AND FOUND THAT IT WAS RECOMMENDED 0.5 UNITS, BUT IT WAS DELIVERED 6.1 UNITS, AND THE CUSTOMER DENIED CHANGING. IT WAS ALSO STATED THAT THE DEVICE WAS EXPOSED TO A HIGH MAGNETIC FIELD. THE DISPLACEMENT TEST WAS PERFORMED AND PASSED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65163 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAH

    Patients

    Seq Age Sex Outcome Treatment
    1