BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933264 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86961
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ELECTRONIC ASSEMBLY. UNABLE TO VERIFY BUTTON KEYPAD DUE TO BLANK DISPLAY ANOMALY. MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP NOTED. NO UNEXPECTED VIBRATING ALARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS AT A DIABETES CAMP AND IT RAINED, THEN THE INSULIN PUMP WAS NOT FUNCTIONING. THE MOTHER MENTIONED THAT DIABETES EDUCATOR AT THE CAMP STATED INDICATED THE DEVICE WAS ALARMING. THE BLOOD GLUCOSE WAS UNKNOWN. THEN THE MOTHER CALLED BACK AND STATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CALLER STATED THAT THE DEVICE WAS VIBRATING WITHOUT AN ALARM ALERT AND WENT BLANK DISPLAY IMMEDIATELY AFTER IT WAS EXPOSURE TO MOISTURE. ADVISED THE MOTHER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409342 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 12 YR