BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2781600 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-90008
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    THE CUSTOMER REPORTED BEING IN THE HOSPITAL DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 300MG/DL. THE CUSTOMER EXPERIENCED CHEST PAINS AND VOMITING. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND SETTINGS WERE CORRECT. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. SUGGESTED THE CUSTOMER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. INSTRUCTED THE CALLER TO CHANGE THE ENTIRE RESERVOIR AND INFUSION SET. THE CUSTOMER REQUESTED THAT THE DEVICE BE REPLACED. THE CALLER CALLED BACK TO PERFORM THE HIGH PRESSURE TEST AND PASSED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP IS FUNCTIONING AS DESIGNED. THE CUSTOMER MENTIONED THAT SHE NOTICED THE CANNULA WAS BENT, BUT THE INSULIN PUMP DID NOT ALARM. FOUND THAT THE CUSTOMER USES THE QUICK SERTER AND PINCHES AN INCH OF THE SKIN DURING THE INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization