BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143009 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30183
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO 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 THAT THE CUSTOMER HAD A CHECK SETTINGS ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 547 MG/DL. CUSTOMER TREATED WITH INJECTIONS. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP. CUSTOMER WAS ASSISTED WITH REMOVING THE RESERVOIR AND REWINDING THE PUMP. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. CUSTOMER STATED THAT HE DID NOT HAVE A TUBING CLAMP. A TUBING CLAMP WILL BE SENT TO THE CUSTOMER AND CUSTOMER WILL CALL BACK TO CONTINUE TROUBLESHOOTING. CUSTOMER WAS ALSO ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR, AND INSULIN. IT WAS EXPLAINED THAT HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY SITE/SET ISSUES. CUSTOMER WAS NOT INTERESTED IN CONTINUING TO TROUBLESHOOT. CUSTOMER HAS ALREADY CHANGED HIS INFUSION SET BEFORE CALLING. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603506 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR