BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211922 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44710
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    July 30, 2014
    Report Date
    September 30, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE WAS NOT SURE HOW THE INSULIN PUMP DELIVERED TOO MUCH INSULIN. EVENT OCCURRED MONTHS AGO CUSTOMER DID NOT KNOW. CUSTOMER WAS ABLE TO STOP IT AND SHE DRANK A LOT OF COKE. CUSTOMER STATED SHE SAW THE URGENT MEDICAL DEVICE INFO AND EXPLAINED IT. ALTHOUGH CUSTOMER STATED SHE DID NOT PRESS THE BUTTON BEFORE THE OVER DELIVERY. CUSTOMER STATED SHE HAD LOW BLOOD GLUCOSE AND WANTED TO KNOW HOW MUCH SHE HAD TO EAT FOR HER BLOOD GLUCOSE TO COME UP. CUSTOMER STATED SHE HAD TO MANUALLY INPUT BLOOD GLUCOSE INTO THE DEVICE AND THEN SHE PRESSED ACT. THEN SHE WOULD SEE BY GOING DOWN WHAT THE NEGATIVE WAS TO HER BLOOD GLUCOSE TO COME UP. THE DEVICE WOULD TELL HER HOW MANY CARBOHYDRATES SHE NEEDED. BUT THE DEVICE STARTED TO DELIVER A BOLUS; SHE WAS ABLE TO STOP IT. IT SEEMED CUSTOMER MIGHT HAVE ACCIDENTLY PRESSED A BUTTON AND NOT HAD A SCROLL RAP ISSUE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692933 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 62 YR