BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3133582 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-94157
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    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 THAT THE PARAMEDICS CAME TO HER HOUSE DUE TO LOW BLOOD GLUCOSE OF 47MG/DL. THE CUSTOMER THOUGHT SHE WAS STROKING AND COULD NOT TALK, BUT THEY NOTICED THAT SHE HAD A BRACELET THAT SHOWS SHE IS DIABETIC. THE CUSTOMER STATED THAT IT TOOK ABOUT THREE HOURS TO GET HER SUGAR BACK UP. THE CUSTOMER MENTIONED THAT AFTER COMING BACK FROM THE GROCERY STORE, SHE WENT TO LIE DOWN. THE CUSTOMER STATED THAT SHE WAS TOLD TO TURN OFF HER INSULIN PUMP. THE NEXT DAY ,SHE WOKE UP WITH HIGH GLUCOSE LEVEL OF 598MG/DL, AND SHE TURNED ON THE INSULIN PUMP. THE GLUCOSE READING AT TIME OF CALL WAS 135MG/DL. THE CALLER STATED THAT NIGHT BEFORE, SHE HAD A SUPPER AND A COOKIE, BUT SHE DID NOT BOLUS. HER BLOOD GLUCOSE WAS 99MG/DL AT BEDTIME, AND WHEN SHE WOKE UP HER GLUCOSE LEVEL WAS READING 63MG/DL. THE CUSTOMER REQUESTED ASSISTANCE TO CHANGE HER BASAL, BUT SHE WAS ADVISED TO CONTACT HER DOCTOR REGARDING HER LOW AND HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235044 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention