BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2931805 · Received January 28, 2013

    Report

    Report Number
    2032227-2013-00375
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 20 MMOL/L, VOMITING, KETONES AND NO DELIVERY ALARMS. IT WAS STATED THAT THE CUSTOMER CHANGED THE INFUSION SET, BUT CONTINUED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS, AND WAS TAKEN TO THE HOSPITAL FOR TREATMENT. IT WAS STATED THAT THE CUSTOMER WENT BACK ON THE INSULIN PUMP AFTER THE HOSPITALIZATION, AND EXPERIENCED NORMAL BLOOD GLUCOSE LEVELS UNTIL THE EVENING, WHEN THEY BEGAN TO ELEVATE AGAIN. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. HOWEVER, THE DOCTOR AND MOTHER DID NOT TRUST THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37965 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization