BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232425 · Received August 26, 2011

    Report

    Report Number
    2032227-2011-02178
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO 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 TREATED BY THE PARAMEDICS AFTER SHE WAS FOUND UNRESPONSIVE WITH A BLOOD GLUCOSE READING OF 33 MG/DL. THE MOTHER REVIEWED THE BOLUS HISTORY, AND FOUND A BOLUS OF 8.0 UNITS WAS DELIVERED PRIOR TO THE EVENT. THE CUSTOMER STATED THAT SHE DID NOT PROGRAM THIS BOLUS. THE CALLER STATED THAT THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR THE PAST THREE DAYS. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE PROGRAMMING WAS INCORRECT. THE TIME WAS PROGRAMMED TO PM INSTEAD OF AM, WHICH WOULD'VE AFFECTED THE CUSTOMER'S BASAL RATE DELIVERIES. ALSO, THE INSULIN PUMP WAS NOT CALCULATING DAILY TOTALS CORRECTLY. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD NEED TO 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 23 YR Required Intervention