BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4821161 · Received June 5, 2015

    Report

    Report Number
    2032227-2015-17978
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER CALLED AND REPORTED GOING TO THE EMERGENCY ROOM WITH DIABETIC KETOACIDOSIS AND HER BLOOD GLUCOSE WENT UP TO 572 MG/DL. THE CUSTOMER'S SYMPTOMS INCLUDED POLYDIPSIA, POLYURIA AND VOMITING. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE WHOLE BOTTOM PANEL OF THE CUSTOMER'S INSULIN PUMP WOULD COME OFF, AFTER CUSTOMER DROPPED IT IN THE BATHROOM. IT WAS ADVISED THAT THE CUSTOMER DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. IT WAS ADVISED THE DEVICE WOULD BE REPLACED AND AGREED UPON THAT THE PRODUCT WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365030 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization