BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2221257 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-82595
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 SEIZURE AND LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 202 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING UNEXPLAINED LOW GLUCOSE FOR THE PAST DAY. IT WAS STATED THAT THE CUSTOMER'S LOW GLUCOSE WAS TREATED WITH A GLUCOSE SHOT. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER PROGRAMMED A BOLUS OF 22.7 UNITS THE NIGHT BEFORE AND THE INSULIN PUMP ALARMED MOTOR ERROR. THEN THE INSULIN PUMP PROGRAMMED 6.0 UNITS. THE MOTHER STATED THAT THE CUSTOMER DID NOT PROGRAM THE 22.7 UNITS BOLUS OR 6.0 UNITS BOLUS. THE CUSTOMER WAS UNSURE IF THE NUMBERS WERE RAMPING ON THEIR OWN, AND POSSIBLE HAD AN OVER-BOLUS. RAN A DISPLACEMENT AND SELF TEST AND THE INSULIN PASSED THE TESTS. THE CUSTOMER ALSO REPORTED RECEIVING NO DELIVERY ALARM. 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-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization