BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933269 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86968
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR. CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND MINOR SCRATCHED DISPLAY WINDOW NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE INSULIN PUMP HAD A BUTTON ERROR. SHE DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK UP PLAN. THE BLOOD GLUCOSE READING WAS 200 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409761 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR