BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2233980 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82777
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 472 MG/DL. THE CUSTOMER STATED THAT THE EVENTS LEADING TO HIS ADMISSION WAS KETONES. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST DAY. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND FOUND THAT THE CUSTOMER ALREADY CHANGED THE SETTINGS AND HAD AN INCORRECT AMOUNT OF INSULIN FOR HIS FILL CANNULA TEST. RAN A FIXED PRIME TEST AND THE TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST AT TIME OF CALL. FOUND THAT THE CUSTOMER WAS NOT PINCHING HIS SKIN AND WAS INSERTING HIS INFUSION SET MANUALLY. ADVISED THE CUSTOMER THAT SHE DOES NOT NEED TO PINCH HIS SKIN WHEN INSERTING MANUALLY. NO FURTHER INFORMATION 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 MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization