BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090385 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23065
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS RECEIVING NO DELIVERY ALARMS ON THE INSULIN PUMP ON SEVERAL OCCASIONS, INCLUDING (B)(6) 2014, HE STATED HE RECEIVED SIX OR SEVEN OF THE NO DELIVERY ALARMS WHILE TRYING TO BOLUS. AT THE TIME OF THE REPORT, THE CUSTOMER'S BLOOD GLUCOSE WAS 169 MG/DL. THE CUSTOMER WAS ASSISTED IN PERFORMING A 5.0 UNIT FIXED PRIME, DURING WHICH INSULIN DID EXIT. THE CUSTOMER STATED HE CHANGED HIS INFUSION SET ON (B)(6) 2014 AND IT LOOKED NORMAL WHEN HE TOOK IT OUT. HE STATED HE HAD TO BOLUS TWO TO THREE TIMES TO GET THE CORRECT AMOUNT OF INSULIN. THE CUSTOMER STATED HE RECEIVED ANOTHER NO DELIVERY ALARM IN THE MORNING OF (B)(6) 2014, AND WAS ADVISED TO CHANGE THE ENTIRE SET, WHICH HE DID NOT WISH TO DO. THE CUSTOMER HAD ALREADY THROWN OUT THE SET. IT WAS ADVISED TO TROUBLESHOOT IN THE FUTURE WHEN THE ISSUES WERE OCCURRING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568561 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR UNOMEDICAL INSULIN INFUSION SET