BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110472 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27368
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    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

    CUSTOMER REPORTED A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. SHE STATED THAT SHE HAD NOT RECEIVED ANY ALARMS AND THAT THE BLOOD GLUCOSE HAD BEEN AS HIGH AS 479 MG/DL AND LATER WENT UP TO 556 MG/DL. SHE REPORTED SYMPTOMS OF ITCHINESS, NAUSEA, VOMITING, THIRST AND ABDOMINAL PAIN. CUSTOMER WAS TREATED WITH MANUAL INJECTION. SHE STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. SHE DID FIND AIR BUBBLES AND WAS ASSISTED IN PRIMING THEM OUT. SHE STATED THAT THERE WERE NO LEAKS BUT THAT THE BUBBLES HAD NOT MOVED. SHE STATED THAT THE BASAL RATES AND BOLUS WIZARD SETTINGS WERE CORRECT. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST ON THE SECOND TRY. SHE REMOVED THE INFUSION SET AND STATED THAT THE NEEDLE WAS NOT BENT OR OCCLUDED AND THAT THE SITE WAS NOT SORE OR IRRITATED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592447 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization