BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930898 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86888
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH NO ACT BUTTON RESPONSE DUE TO FLATTENED DOME SWITCH BUTTON. NO BUTTON ERROR ALARM NOTED. UNABLE TO PERFORM REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST DUE TO NO BUTTON RESPONSE. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, 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 A BUTTON ERROR ALARM THAT HE IS NOT ABLE TO CLEAR. CUSTOMER STATED THAT HE WORKS IN CONSTRUCTION AND MIGHT HAVE PUSHED A BUTTON FOR A LONG TIME LEADING TO THE BUTTON ERROR. CUSTOMER ALSO STATED THAT HE LOCKS THE BUTTONS, HOWEVER THEY UNLOCK THEMSELVES. CALLER REPORTED THAT THE INSULIN PUMP SHOWS THAT IT IS DELIVERING INSULIN, HOWEVER THERE IS NO INSULIN COMING OUT. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 103 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408612 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR