BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090372 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23066
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS EXPERIENCING HIGH BLOOD GLUCOSE, DESPITE INCREASING BOLUS AMOUNT, CHANGING INFUSION SET AND DIET. THE CUSTOMER STATED THE INSULIN PUMP DID NOT HAVE CRACKS AND INSULIN WAS EXITING, BUT HIS DOCTOR RECOMMENDED THAT THE INSULIN PUMP BE REPLACED AND HAD NO OTHER SUGGESTIONS. THE CUSTOMER'S BLOOD GLUCOSE WAS 432 MG/DL, WHICH WAS TREATED WITH A BOLUS FROM THE INSULIN PUMP. HER SYMPTOMS WERE NAUSEA, DRY MOUTH AND THIRST. THE CUSTOMER'S BACK-UP PLAN WAS INJECTION. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR WAS FOUND IN THE TUBING. THE CUSTOMER DID NOT HAVE A TUBING CLAMP WITH WHICH TO CONTINUE TROUBLESHOOTING. THE CUSTOMER STATED THE INSULIN WAS CLEAR, AND THE INFUSION SET CANNULA WAS NOT BENT OR OCCLUDED, NOR WAS THE INSERTION SITE SORE. SHE WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568195 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR