BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2854459 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-91061
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 18, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    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 LOW BLOOD GLUCOSE OF 3.2MG/DL. THE CUSTOMER STATED THAT SHE TOOK INSULIN FIRST TO COVER THE FOOD AND THEN HE DID NOT EAT. TROUBLESHOOTING COULD NOT BE COMPLETED AS CUSTOMER DID NOT HAVE HIS GLASSES. THEN THE CUSTOMER CALLED BACK TO REVIEW THE PROGRAMMING AND IT WAS CORRECT. THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. PERFORMED A DISPLACEMENT TEST AND PASSED. WHILE CALLING WAS FOUND THAT THE CUSTOMER WAS TAKING A MEDICATION THAT CAN RAISE HIS BLOOD GLUCOSE LEVEL. THE CUSTOMER MENTIONED RECEIVING MULTIPLE NO DELIVERY ALARMS. REVIEWED THE DAILY TOTALS AND NOTICED THAT SOME OF THE DAYS WERE SHOWING 0.0 UNITS, BUT IT SHOWED THE DAILY TOTALS FOR THE DAY BEFORE. ADVISED THE CUSTOMER THAT THE DEVICE MAY HAVE BEEN STORED WITHOUT A BATTERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization