BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2212962 · Received August 8, 2011

    Report

    Report Number
    2032227-2011-01994
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO 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. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 768 MG/DL. THE CUSTOMER STATED THAT SHE BEGAN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS THE NIGHT BEFORE BEING HOSPITALIZED. THE CUSTOMER WAS ALSO URINATING EXCESSIVELY. THE CUSTOMER STATED THAT SHE HAD DINNER, BUT DIDN'T BOLUS BECAUSE SHE HAD A LOT GOING ON AT THAT TIME. THE ALARM HISTORY WAS REVIEWED, AND FOUND NO DELIVERY ALARMS JUST PRIOR TO THE HOSPITALIZATION. THE CUSTOMER STATED THAT HER DOCTOR WANTED THE INSULIN PUMP REPLACED. FURTHER TROUBLESHOOTING WAS DECLINED. 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 MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization