BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090081 · Received May 5, 2011

    Report

    Report Number
    2032227-2011-01173
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 30, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 838 MG/DL. THE CUSTOMER ALSO HAD SEPSIS AND RENAL FAILURE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. HOWEVER, FOUND THAT THERE WERE NO BOLUS DELIVERIES IN THE BOLUS HISTORY FOR (B)(6) 2011. THE NURSE STATED THAT THE CUSTOMER DID BOLUS ON THAT DAY. ADVISED THE NURSE THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE HISTORY ANOMALY. 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-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization SET, MMT-397, LOT 9202054.| UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION