BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2944530 · Received February 5, 2013

    Report

    Report Number
    2032227-2013-00480
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS ADMITTED IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 567MG/DL AND KETONES. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE CUSTOMER HAS BEEN WEARING THE INSULIN PUMP ALL ALONG. WHEN THE DOCTOR CHECKED TO SEE IF HE WAS RECEIVING INSULIN, THEY SAW 93 UNITS LEFT IN THE STATUS SCREEN, BUT THE RESERVOIR WAS EMPTY. REVIEWED THE ALARM HISTORY AND FOUND NO DELIVERY AND BATTERY OUT OF LIMIT ALARM. THE MOTHER STATED THAT SHE IS NOT SURE IF THE CUSTOMER CHANGED THE INFUSION SER WHEN HE RECEIVED THE ALARM. THE BOLUS HISTORY WAS CHECKED AND FOUND THAT HIS LAST BOLUS WAS THE DAY OF THE EVENT. HAD THE MOTHER TO REWIND AND PRIME WITHOUT THE RESERVOIR AND THE SCREEN SHOWED 40.3 UNITS LEFT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48134 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization