BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190366 · Received July 28, 2011

    Report

    Report Number
    3004209178-2011-82333
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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 UNK 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 THAT HIS INSULIN PUMP FAILED THE BATTERY TEST. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE IS USING THE PROPER BATTERIES. DURING THE CALL, THE CUSTOMER MENTIONED BEING IN THE HOSPITAL FOR PNEUMONIA AND HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO MENTIONED THAT HIS HIGH GLUCOSE WAS DUE TO BAD INSULIN, AND NOTHING HAS TO DO WITH THE INSULIN PUMP. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE IS NORMAL SINCE THE REPLACEMENT OF THE INSULIN PUMP WAS CONNECTED TO HIM. 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization