BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2081272 · Received April 26, 2011

    Report

    Report Number
    2032227-2011-01055
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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 HE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 490 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER STATED THAT HE BOLUSED SEVERAL TIMES, BUT HIS BLOOD GLUCOSE LEVELS REMAINED ELEVATED. THE CUSTOMER EXPERIENCED VOMITING, FREQUENT URINATION AND DRY MOUTH. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. HOWEVER, THE BOLUS HISTORY DID NOT MATCH WITH THE DAILY TOTALS. ADVISED 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 INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization