BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190334 · Received July 28, 2011

    Report

    Report Number
    3004209178-2011-82323
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER LOST CONSCIOUSNESS. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE FOR THE PAST WEEKS. IT WAS STATED THAT CUSTOMER'S MOST RECENT GLUCOSE READING WAS 34MG/DL. IT WAS STATED THAT THE INSULIN PUMP WAS SQUIRTING OUT DURING PRIME, BUT THE CUSTOMER WAS NOT CONNECTED DURING THE PROCESS. HAD CUSTOMER TO REMOVE THE RESERVOIR AND TO REWIND THE INSULIN PUMP, BUT IT ALARMED AN ERROR. ADVISED THE CALLER THAT CUSTOMER SHOULD CONTINUE ON MANUAL INJECTIONS UNTIL THE REPLACEMENT OF THE INSULIN PUMP ARRIVES. NO FURTHER INFO 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-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization