BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110471 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27361
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 23, 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
    TX
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH HIS INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 600 MG/DL AND CUSTOMER TREATED WITH A MANUAL INJECTION. CUSTOMER STATED THAT HE WENT TO THE HOSPITAL LAST NIGHT BECAUSE HE HAD HIGH BLOOD GLUCOSE LEVELS. THE EMERGENCY ROOM LOWERED HIS BLOOD GLUCOSE LEVEL AND RELEASED HIM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 468 MG/DL AT THE TIME OF THE EMERGENCY ROOM VISIT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS LOWERED TO 132 MG/DL AT THE EMERGENCY ROOM VISIT. CUSTOMER REPORTED THAT HE BROKE HIS BELT CLIP. TROUBLESHOOTING WAS PERFORMED, BUT CUSTOMER WAS UNABLE TO LOCATE THE TUBING CLAMP. CUSTOMER WAS ADVISED TO CALL BACK ONCE HE RECEIVES THE TUBING CLAMP TO CONTINUE TROUBLESHOOTING. ON (B)(6) 2014, CUSTOMER STATED THAT HIS BLOOD GLUCOSE LEVEL WAS 89 MG/DL. CUSTOMER REPORTED THAT HIS PUMP IS WORKING FINE. CUSTOMER STILL DID NOT HAVE THE TUBING CLAMP. CUSTOMER WAS ADVISED TO CALL BACK TO FINISH HIGH PRESSURE TESTS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591878 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization