BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160712 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94584
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6), 2013, SHE WAS RUNNING HIGH AND DID A FULL INFUSION SET CHANGE INCLUDING INSULIN. THE NEXT MORNING HER GLUCOSE LEVEL WAS 36M G/DL; THEN SHE DRANK JUICE AND FELL ASLEEP. THE CUSTOMER STATED THAT HER HUSBAND WOKE HER UP BECAUSE SHE WAS SWEATING. HE TRIED TO GIVE HER JUICE AND CAKE, BUT SHE DID NOT EAT OR WAKE, AND WAS UNRESPONSIVE. THE PARAMEDICS WERE CALLED AND TREATED HER WITH AN INSULIN DRIP. LATER, WHEN SHE WOKE UP HER BLOOD GLUCOSE WAS OVER 600MG/DL, AND HER GLUCOSE LEVEL WAS TREATED WITH A MANUAL INJECTION. HOWEVER, THE CUSTOMER WAS STILL RUNNING HIGH AND WENT TO THE EMERGENCY ROOM. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261049 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization