BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202528 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82457
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DEHYDRATION, NAUSEA, AND HIGH BLOOD GLUCOSE OF 345MG/DL. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST FOUR TO FIVE DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 125MG/DL, AND SHE WAS TREATED AT THE HOSPITAL. TROUBLESHOOTING COULD NOT BE PERFORMED BECAUSE THE CUSTOMER PUT HER INSULIN PUMP IN SUSPEND MODE WHILE SHOWERING AND SHE FORGOT TO RECONNECT TO THE INSULIN PUMP. THE CUSTOMER STATED THAT THE SUSPEND REMINDER KEPT ALARMING, BUT SHE IGNORED IT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization QUICK-SET: 23| PARADIGM 9 MM CATHETER| UNOMEDICAL INFUSION SET: MMT-397