BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190328 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-82241
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 INSULIN PUMP ALARMED MOTOR ERROR DURING NIGHT. IT WAS STATED THAT THE CUSTOMER CLEARED THE ALARM AND BOLUSED. THEN, THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND KETONES. IT WAS STATED THAT THE CUSTOMER IS A TEENAGER AND HE WAS AT THE SCHOOL AT TIME OF CALL. TROUBLESHOOTING COULD NOT BE PERFORMED. THE MOTHER STATED THAT SHE DOES NOT KNOW WHAT EXACTLY HAPPENED. 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-522WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization