BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4161886 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36087
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSIN TEST, PRIME TEST, AND EXCESSIVE NO DELIVERY ALARM TEST. NO EXCESSIVE NO DELIVERY ALARM WAS NOTED. THE INSULIN PUMP HAD A CRACKED CASE AT A DISPLAY WINDOW CORNER AND A CRACKED RESERVOIR TUBE LIP.

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD 10 LOW BLOOD GLUCOSE EVENTS IN ONE DAY. THE MOTHER ALSO REPORTED THAT A NO DELIVERY ALARM OCCURRED DURING THE CUSTOMER'S BOLUS DELIVERY. THE MOTHER STATED THE RESERVOIR AND INFUSION SET WAS REPLACED AND THE NO DELIVERY ALARM OCCURRED AGAIN. THE MOTHER BELIEVED IT WAS UNSAFE FOR HER DAUGHTER TO USE THE INSULIN PUMP. THE MOTHER ALSO REPORTED HER DAUGHTER'S LAST KNOWN BLOOD GLUCOSE WAS 135 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639949 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR