BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2233950 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82791
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 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
    NM, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSOS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP GAVE HIM 100 UNIT OF INSULIN CAUSING HIS BLOOD GLUCOSE TO DROP. THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 50 MG/DL. THE CUSTOMER STATED THAT HE TRIED TO PRIME, BUT THE INSULIN PUMP WAS REWINDING. ATTEMPTED TO TROUBLESHOOT AND THE INSULIN PUMP HAD AND ERROR ALARM. THE CUSTOMER ALSO REPORTED THAT HE RECEIVED A MOTOR ERROR PRIOR HAVING THE LOW BLOOD GLUCOSE EVENT. 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 37 YR Hospitalization