BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181260 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39487
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 AT 9:30PM FOR HIGH BLOOD GLUCOSE LEVELS OF 710 MG/DL AND DIABETIC KETOACIDOSIS. CUSTOMER STATED THAT THE PUMP IS NOT GIVING HIM INSULIN. CUSTOMER TOOK MANUAL INJECTIONS AND THE BLOOD GLUCOSE LEVELS SEEM TO BE COMING DOWN. CUSTOMER HAD THE FOLLOWING SYMPTOMS: DRY MOUTH AND HIS SHOULDERS STARTED HURTING. CUSTOMER WAS TREATING WITH THE PUMP AND IS NOW TREATING WITH MANUAL INJECTIONS. CUSTOMER RAN A MANUAL PRIME AND THE INSULIN DID EXIT THE TUBING. PUMP SETTINGS AND HISTORY WERE REVIEWED AND WERE CORRECT. A TUBING CLAMP WILL BE SENT AND CUSTOMER WILL NEED TO CALL BACK TO COMPLETE TROUBLESHOOTING. CUSTOMER STATED THAT THE INFUSION SET IS STILL IN HIS BODY AND HE JUST REMOVED IT. CUSTOMER ALSO STATED THAT IT WAS CURVED A LITTLE, BUT NOT BENT OR KINKED. CUSTOMER CALLED BACK AND THE PUMP FAILED THE HIGH PRESSURE TEST TWICE. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660904 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization