BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252170 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52864
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S DAUGHTER REPORTED THAT MOTHER HAD BEEN HAVING HIGH BLOOD GLUCOSE EVEN AFTER SET CHANGE. CUSTOMER BLOOD GLUCOSE WAS 352 MG/DL, SO SHE GAVE MANUAL INSULIN SHOT WHICH CAUSED HER MOTHER'S BLOOD GLUCOSE TO GO DOWN TO 28MG/DL. SHE GAVE HER ACTING GEL AND BY THE TIME AMBULANCE GOT TO THEM HER BLOOD GLUCOSE WAS AT 100 MG/DL. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 327 MG/DL. IT WAS FOUND THAT THERE WAS AIR BUBBLE IN THE TUBING. ASSISTED THE CUSTOMER TO REMOVE THE AIR BUBBLE. CUSTOMER STATED DOES NOT HAVE TUBING CLAMP. CUSTOMER WILL CONTACT HEALTH CARE PROVIDER TO FIND OUT WHAT DOSAGE TO GIVE TO HER MOTHER. CUSTOMER WILL CHANGE THE ENTIRE INFUSION SET. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736282 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR