BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5657134 · Received May 16, 2016

    Report

    Report Number
    3004209178-2016-48629
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    April 23, 2016
    Report Date
    April 23, 2016
    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

    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 OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP PASSED SELF TEST, UNEXPECTED RESTART ERROR TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO BEEP ANOMALY NOTED. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INSULIN PUMP HAD A BEEP ANOMALY. THE PATIENT'S BLOOD GLUCOSE LAST NIGHT WAS 56 MG/DL AND HER BLOOD GLUCOSE IN THE MORNING WAS 296 MG/DL. TROUBLESHOOTING WAS INITIATED FOR THE BEEP ANOMALY. THE CUSTOMER STATED THAT THE DEVICE WAS BEEPING BUT WHEN SHE CHECKED THE RESERVOIR THERE WAS STILL INSULIN LEFT. THE CUSTOMER WAS ASSISTED WITH SETTING THE ALERT TYPE TO VIBRATE SINCE SHE IS LEGALLY BLIND. HOWEVER, WHEN THE SELF TEST WAS PERFORMED ON THE UNIT THE TEST FAILED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT DEVICE WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310894 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 55 YR