BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2072538 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-81163
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPERGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 578 MG/DL. THE CUSTOMER'S FATHER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD BEEN EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S FATHER ALSO STATED THAT THE CUSTOMER USES A QUICK-SET INFUSION SET AND LAST CHANGED HIS INFUSION SET THE DAY OF THE EVENT. THE CUSTOMER'S FATHER MENTIONED THAT THE DOCTOR BELIEVES THE INSULIN PUMP IS NOT FUNCTIONING PROPERLY. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE FIXED PRIME AND THE HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    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 15 YR Hospitalization UNOMEDICAL QUICK-SET INSULIN INFUSION SET