BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2062689 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-81012
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TREATED BY AN ENDOCRINOLOGIST FOR ELEVATED BLOOD GLUCOSE LEVELS. THE NURSE PRACTITIONER STATED THAT THE CUSTOMER WAS STATIONED IN (B)(6) AND THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN RUNNING HIGH. THE CUSTOMER STATED THAT SHE REC'D AN ALARM AND THE BOTTOM OF HER INSULIN PUMP HAD CAME OFF BEFORE BUT HAD BEEN REPAIRED AT OUR LOCAL OFFICE IN (B)(6). THE CUSTOMER THEN STATED THAT PRIOR TO THE EVENT, SHE HAD REC'D THE SAME ALARM AND HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS, WHICH PROMPTED HER TO SEE A LOCAL ENDOCRINOLOGIST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization