BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252169 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52863
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE FOR THE PAST COUPLE OF DAYS. CUSTOMER STATED HIS BLOOD GLUCOSE WAS OVER 600 MG/DL AND TREATED WITH SYRINGE OF 15 UNITS OF INSULIN. CUSTOMER STATED THAT HE THOUGHT HE HAD BEEN GIVING HIMSELF BOLUSES. CUSTOMER STATED WAS NOT FEELING GOOD AND DECLINED TO TROUBLESHOOT. CUSTOMER LEFT FOR VACATION AND DOES NOT HAVE THE TUBING CLAMP. CUSTOMER STATED THAT THEY HAVE BACK UP PLAN. ADVISED THE CUSTOMER TO MONITOR HIS BLOOD GLUCOSE AND TUBING CLAMP WILL BE SENT AND TO REPORT BACK ONCE RECEIVED SO WE CAN TROUBLESHOOT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738416 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR