BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2990659 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-91624
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 800MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE TUBING BROKE OFF AND SHE WAS DISCONNECTED FROM THE INSULIN PUMP IN THE EARLY EVENING AND WAS WITHOUT INSULIN ALL NIGHT. THE BLOOD GLUCOSE WAS TREATED WITH MANUAL INJECTIONS AND CURRENTLY SHE IS ON AN INSULIN DRIP. THE CUSTOMER MENTIONED THAT THE DEVICE IS CRACKED AT THE RIGHT AND LEFT CORNERS OF THE SCREEN AND ALL THE WAY AROUND TO THE BACKSIDE. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94298 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization