BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2070242 · Received April 19, 2011

    Report

    Report Number
    3004209178-2011-81116
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 12, 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 TREATED BY HIS DOCTOR FOR HIGH BLOOD GLUCOSE LEVELS OF 336 MG/DL. THE CUSTOMER STATED THAT HIS INSULIN PUMP HAD A BLANK DISPLAY AND WOULD NOT TURN ON. THE CUSTOMER THEN STATED THAT HIS BLOOD GLUCOSE LEVELS WERE HIGH BECAUSE HE DID NOT KNOW HOW MUCH INSULIN TO TAKE. IT WAS ADVISED THAT THE CUSTOMER SEE HIS DOCTOR AND THE CUSTOMER STATED THAT HE WAS DOING SO AT THE TIME. THE CUSTOMER ALSO STATED THAT A BATTERY CHANGE AND A BATTERY REST DID NOT RESOLVE THE ISSUE. NOTHING FURTHER WAS REPORTED.

    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-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention