BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4841822 · Received June 12, 2015

    Report

    Report Number
    2032227-2015-18860
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 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 PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME TEST. HOWEVER, THE INSULIN PUMP WAS RECEIVED STUCK ON A MOTOR ERROR ALARM LOOP THAT OCCURRED DURING A BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A CRACKED RESERVOIR TUBE LIP AND A BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM AND AN ADDITIONAL ERROR ALARM. CUSTOMER'S MOTHER STATED THAT THE ERROR ALARMS OCCURRED DURING THE REWIND PROCESS AND DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THEM. THE CUSTOMER'S MOTHER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384347 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR