BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202574 · Received August 5, 2011

    Report

    Report Number
    2032227-2011-01980
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 26, 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
    NJ, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. MFG. REPORT 1 OF 2, MEDWATCH REPORT # 3004209178-2011-82475.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING TREATED BY HIS DOCTOR HIS HIGH BLOOD GLUCOSE OF 425 MG/DL. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST TWENTY FOUR HOURS. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND FOUND THAT THE CUSTOMER HAS TAKEN MORE INSULIN THROUGH BOLUS HISTORY COMBINED WITH THE TWENTY FOUR HOUR BASAL TOTAL THAN WHAT IS CALCULATING IN THE DAILY TOTALS. THE CUSTOMER STATED THAT THE DAILY TOTAL SHOWS A DIFFERENCE OF 0.8 UNITS. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    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-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization QUICK-SET, 23| UNOMEDICAL INFUSION SET: MMT-397| PARADIGM, 9 MM CATHETER