BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090533 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-17804
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 A LOW BLOOD GLUCOSE EVENT AND REQUIRED MEDICAL INTERVENTION BY EMERGENCY MEDICAL SERVICES. THE CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WAS 27 OR 37 MG/DL WHEN HIS WIFE MADE THE EMERGENCY CALL. HE STATED THAT HE HAD ADMINISTERED A BOLUS BEFORE HIS MEAL AND THEN WENT UNCONSCIOUS. HE WAS TREATED WITH SUGAR AND WATER. THE BLOOD GLUCOSE READING ROSE TO 300 MG/DL AFTER TREATMENT. THE CUSTOMER REQUESTED CLARIFICATION OF THE SAFETY NOTICE REGARDING THE SCROLL WRAP; EXPLAINED THAT THERE HAD BEEN SOME INSTANCES WHERE OVER DELIVERY OF INSULIN WAS OBSERVED BY MANUAL BOLUSES DELIVERING THE MAXIMUM BOLUS AMOUNT. HE NOTED THAT HE ALSO HAD CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND SOME AMPUTATIONS FOR HIS CONDITION ALREADY. HE DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569594 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention