BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4181396 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39654
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD LOWER THAN USUAL BLOOD GLUCOSE LEVELS FOR THE PAST WEEK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 50 MG/DL. CUSTOMER TREATED WITH ORANGE JUICE AND FOOD. CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR ABOUT 1 WEEK. CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. CUSTOMER WAS NOT DISCONNECTED DURING THE REWIND/PRIME SEQUENCE. CUSTOMER STATED THAT HE HAD DECREASED BASAL BY 5%. CUSTOMER STATED THAT THE RESERVOIR IS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. CUSTOMER CHECKED ALL HIS SETTINGS AND STATED THAT HE DOES NOT USE THE BOLUS WIZARD. CUSTOMER CALCULATES ON HIS OWN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660461 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR