BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2200793 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-82376
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 1, 2007
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 22MG/DL. THE CUSTOMER STATED THAT HIS GLUCOSE LEVEL DROPPED BECAUSE HE DID NOT EAT AND DID NOT CHECK HIS SUGAR LEVEL PRIOR TO SLEEPING. THE CUSTOMER STATED THAT HE WAS NOT MAINTAINING HIS SUGARS CORRECTLY. THE CUSTOMER ALSO STATED BEING HOSPITALIZED ON OTHER OCCASIONS AND THE MOST RECENT WAS A MONTH AND A HALF AGO. ADVISED THE CUSTOMER TO MONITOR HIS GLUCOSE LEVEL AND FOLLOW HIS DOCTOR'S INSTRUCTIONS. 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 35 YR Hospitalization