BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2123169 · Received June 10, 2011

    Report

    Report Number
    2032227-2011-01438
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 CALLED TO REPORT HIGH BLOOD GLUCOSE LEVELS AFTER A ROUTINE VISIT WITH HIS ENDOCRINOLOGIST. THE CUSTOMER STATED THAT HIS DOCTOR MADE CHANGES TO SOME OF HIS BASAL RATES. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. HOWEVER, THE BOLUS DELIVERY TOTALS DID NOT MATCH WITH THE DAILY TOTALS. THE PRIME AND HIGH PRESSURE TESTS PASSED. DAYS LATER, THE CUSTOMER CALLED TO REPORT THAT HE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA AND AN INFECTION IN HIS LEG. THE CUSTOMER DID NOT KNOWN WHY HIS BLOOD GLUCOSE LEVELS WENT SO LOW. THE INSULIN PUMP HAD BEEN REPLACED DUE TO THE ISSUE WITH THE DAILY TOTALS, BUT HE CONTINUED USING THE INSULIN PUMP. 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 68 YR Hospitalization INSULIN INFUSION SET: MMT-397, LOT 9202167| UNOMEDICAL QUICK-SET PARADIGM: