BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4810022 · Received June 1, 2015

    Report

    Report Number
    3004209178-2015-60376
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    March 16, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE 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 DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. THE DEVICE PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, AND EXCESSIVE NO DELIVERY TEST. THE FOLLOWING COSMETIC DAMAGE WAS NOTED: MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE, AND CRACKED RESERVOIR TUBE LIP. NO DATA ANALYSIS WAS PERFORMED DUE TO THE DEVICE BEING RETURNED WITHOUT A BATTERY INSTALLED.

    Additional Manufacturer Narrative · 1

    INFORMATION HAS BEEN UPDATED WHICH WAS NOT INCLUDED WITH INITIAL. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT. THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE, IN THE RANGE OF 400 MG/DL TO 500 MG/DL AND WAS HOSPITALIZED ON (B)(6) 2015. THE CALLER STATED THAT THE CUSTOMER HAS PASSED AWAY IN THE HOSPITAL ON (B)(6) 2015. THE CALLER STATED THAT THE CUSTOMER HAD THE FLU AND COULD NOT KEEP HER BLOOD GLUCOSE DOWN; HER BLOOD GLUCOSE WAS OVER 1000 MG/DL. SHE HYPERVENTILATED, PASSED OUT, WENT INTO A COMA AND HAD NO BRAIN ACTIVITY. SHE WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED FOR A WEEK PRIOR TO PASSING. THE CUSTOMER WAS USING SENSOR BUT WAS NOT WEARING ONE AT THE TIME OF DEATH. SHE HAD HISTORY OF MEDICAL ISSUES DUE TO A CAR ACCIDENT IN 2000. DIFFERENT INFECTIONS SUCH AS STAPH INFECTION, PLATE IN ARM INFECTION. SHE HAD A PARTIAL HIP REPLACEMENT AND STROKES IN THE PAST. BLOOD GLUCOSE, AT THE TIME OF DEATH, WAS UNKNOWN. THE CUSTOMER WAS TAKEN OFF LIFE SUPPORT. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352782 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization