BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181500 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39594
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY ALARM TEST. NO EXCESSIVE NO DELIVERY ALARM WAS NOTED. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES DELIVERIES AND ALL REGISTERED PROPERLY IN THE BOLUS HISTORY. NO BOLUS ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS EXCESSIVELY RECEIVING NO DELIVERY ALARMS. HE STATED THAT HE HAD CHANGED OUT HIS INFUSION SET AND THE ALARM WAS RECURRING. THE CUSTOMER ALSO REPORTED THAT THE ALARM WAS NOT OCURRING DURING A MANUAL PRIME. HE ALSO REPORTED HIS INSULIN DID NOT LOOK CLEAR. THE CUSTOMER ALSO REPORTED RECEIVING A NO DELIVERY ALARM DURING A BOLUS. THE CUSTOMER COULD NOT RECEIVE HIS BOLUS AS A RESULT OF THE ALARM. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT FROM THE TUBING DURING A FIXED PRIME, BUT THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER WAS ADVISED THE ALARM MAY BE CAUSED BY AN INFUSION SET OR RESERVOIR OCCLUSION. CUSTOMER'S BLOOD GLUCOSE WAS 350 MG/DL. HE TREATED HIS BLOOD GLUCOSE WITH THE INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660027 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR