BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202495 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82438
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 25, 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
    CO
    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. 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 HAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE, AND WAS IN THE HOSPITAL FOR OVER A MONTH. THE CUSTOMER STATED THAT SHE WAS TOLD BY THE DOCTOR THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY, AND THAT SHE NEEDS A REPLACEMENT OF THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. FOUND THAT THE CUSTOMER DID NOT HAVE LOW BLOOD GLUCOSE AT TIME OF CALL, AND HER BLOOD GLUCOSE WAS STABLE. REVIEWED THE SETTINGS AND FOUND THAT THE BOLUS HISTORY WAS NOT THERE ANYMORE SINCE SHE HAD NOT USED THE INSULIN PUMP FOR THE PAST TWO MONTHS. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization