BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930711 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03704
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 RECEIVED WITH ALL BUTTONS RESPONDING PROPERLY. NO BUTTON ANOMALIES NOTED. UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING KEYPAD PROBLEMS WITH HIS INSULIN PUMP. SHE STATED THAT THE INSULIN PUMP WRONGLY WENT INTO THRESHOLD SUSPEND AND SHE WAS UNABLE TO DO ANYTHING ABOUT IT. SHE ALSO REPORTED THAT THE BUTTONS ON THE INSULIN PUMP ARE NOT RESPONDING. THE BLOOD GLUCOSE VALUE WAS 105 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE INSULIN PUMP AND REVERT TO A BACKUP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408546 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR