BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2970539 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-91146
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD AN EPISODE OF LOW BLOOD GLUCOSE BECAUSE AN OVER INFUSION OF INSULIN. IT WAS STATED THAT THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS TREATED FOR HYPOGLYCEMIA AT HOME. THE BLOOD GLUCOSE WAS 1.9MMOL/L AT TIME OF THEIR ARRIVAL. IT WAS STATED THAT THE CUSTOMER'S INSULIN PUMP HAD A SQUARE WAVE BOLUS PROGRAMMED, BUT THE CUSTOMER DOES NOT RECOGNIZE PROGRAMMING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74328 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention