BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3994110 · Received August 8, 2014

    Report

    Report Number
    2032227-2014-06614
    Date Received
    August 8, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM NOTED. INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. INSULIN PUMP WAS RECEIVED WITH AN ERROR ALARM AFTER BATTERY CHANGE DUE TO BROKEN SOLDER JOINT ON CAPACITOR. INSULIN PUMP HAD MEMORY LOST DUE TO A21 ANOMALY. INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE WHICH WAS OVER 600 MG/DL. THE PATIENT WAS ADMITTED IN THE HOSPITAL AT 4AM ON (B)(6) 2014 AND HER BLOOD GLUCOSE AT TIME OF EMERGENCY ROOM VISIT WAS 540 MG/DL. CUSTOMER STATED THAT THEY FELT NAUSEATED AND WAS THROWING UP PRIOR TO CHECKING INTO THE EMERGENCY ROOM. CUSTOMER STATED THAT SHE WAS NOT HOOKED TO HER INSULIN PUMP AT THE HOSPITAL FROM 4AM TO 11AM. THE CUSTOMER WAS HELPED WITH TROUBLE SHOOTING AND DISCOVERED THAT HER PUMP WAS NOT DISPLAYING CORRECT BOLUS HISTORY. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. A NEW PUMP WAS SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468377 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| O