BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945590 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04371
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP FUNCTIONED PROPERLY. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD HIGH BLOOD GLUCOSE OF 369 MG/DL. CUSTOMER STATED THAT HER INSULIN PUMP CRACKED AT THE RESERVOIR WINDOW AND WAS NOT WORKING CORRECTLY. CUSTOMER STATED THAT SHE WAS HAVING ISSUES WITH HER RESERVOIR, THE INSULIN PUMP IS UNDER DELIVERING AND IT DID NOT ALARM TO NOTIFY HER OF THE PROBLEM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424727 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR