BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2232581 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-82673
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. IT WAS STATED THAT THE CUSTOMER WAS VOMITING PRIOR TO BEING ADMITTED. THE BLOOD GLUCOSE READING AT THE TIME OF CALL WAS 392 MG/DL. THE MOTHER STATED THAT THE TIME WAS OFF. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND FOUND THAT THERE WAS NO INFO FOR (B)(6), 2011 ON THE ALARM HISTORY AND DAILY TOTALS, BUT THE BOLUS HISTORY SHOWED A BOLUS FOR THIS DAY, AND OTHER BOLUSES THAT TOOK PLACE. THE CUSTOMER ALSO STATED THAT THE BATTERIES WERE NOT WORKING FOR TWO WEEKS AND THE BATTERY WAS CHANGED FIVE TIMES. RAN A FIXED PRIME AND THE INSULIN EXITED. THE MOTHER TRIED TO RUN A HIGH PRESSURE TEST BUT SHE WAS NOT FAMILIAR WITH IT. THE MOTHER STATED THAT THE CUSTOMER HAS WASTED SEVEN INFUSION SETS DUE TO THE INSULIN PUMP ISSUE AND INFUSION SET'S REPLACEMENT WAS REQUESTED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization 6MM PINK| MMT-923| UNOMEDICAL INFUSION SET| MIO SET 23"