BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2870098 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-08039
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS WITH VOMITING AND EXCESSIVE URINATION. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE GREATER THAN 600 MG/DL. THE CUSTOMER ALSO STATED THAT THERE WAS A CRACK ON THE INSULIN PUMP CASING NEAR THE UP ARROW BUTTON. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization