BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2039255 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-80819
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 560 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, SHE THOUGHT SHE HAD STOMACH FLU. THE CUSTOMER ALSO STATED THAT SHE HAS BEEN GETTING EXCESSIVE NO DELIVERY ALARMS. THE CUSTOMER FURTHER STATED THAT SHE USES AN MMT-398 QUICK-SET INFUSION SET, LOT 9201593. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED BOTH THE FIXED PRIME AND THE HIGH PRESSURE TEST.

    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 MED-REL MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization UNOMEDICAL PARADIGM QUICK-SET| INSULIN INFUSION SET, LOT #9201593