BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3962255 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-88280
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 530 MG/DL, AND THE CUSTOMER TREATED WITH A MANUAL INJECTION. THE CUSTOMER STATED THAT SHE HAD JUST RECEIVED A REPLACEMENT INSULIN PUMP, SO SHE DID NOT THINK THAT THE DEVICE WAS THE CAUSE FOR HIGH BLOOD GLUCOSE LEVELS. SHE ALSO REPORTED THAT SHE HAD BEEN INSERTING THE INFUSION SETS INTO HER ABDOMEN FOR OVER 10 YEARS; ADVISED THE CUSTOMER TO CONSULT HER DOCTOR REGARDING POSSIBLE SCAR TISSUE ISSUES. IN A PAST EVENT, THE CUSTOMER ALSO REPORTEDLY HAD ISSUES OF BREAKS AT THE TUBING CONNECTOR BUT WAS UNABLE TO TROUBLESHOOT SINCE THIS WAS A PAST EVENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439602 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention