BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234002 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82778
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 HAVING UNEXPLAINED LOW BLOOD GLUCOSE THE DAY OF CALL. THE CUSTOMER STATED THAT HER GLUCOSE DROPPED TO 47 MG/DL, AND THE PARAMEDICS WERE CALLED. THE CUSTOMER STATED THAT SHE HAD CHECKED HER GLUCOSE LEVEL AND THE BLOOD GLUCOSE METER SHOWED 500 MG/DL. THE CUSTOMER THEN DELIVERED 4.0 UNITS OF INSULIN FOR CORRECTION. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WAS TREATED WITH AN INSULIN DRIP IN THE AMBULANCE. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 200 MG/DL. THE PROGRAMMING TIME, AND DATE WERE CORRECT. THE CUSTOMER STATED THAT THERE IS MORE INSULIN IN THE STATUS SCREEN THAN THE RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention