BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2930685 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-90589
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    July 4, 2012
    Report Date
    January 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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. MFG. REPORT 1 OF 2, MEDWATCH REPORT # 3004209178-2013-90589. MFG. REPORT 2 OF 2, MEDWATCH REPORT # 3004209178-2013-90590.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 400MG/DL. THE MOTHER MENTIONED HAVING MULTIPLE ISSUES AS HIGH READINGS, AIR BUBBLES, AND STRIPPED BATTERY CAP. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE CUSTOMER ALSO WAS ADMITTED ON (B)(6) 2012, AND HER BLOOD GLUCOSE READING WAS 856MG/DL AT THE TIME. THE MOTHER ALSO STATED THAT THE AIR BUBBLES APPEARED WHEN SHE CHANGES THE INFUSION SET. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37336 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization