BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2902447 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-90111
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO MOISTURE DAMAGE INSIDE FORCE SENSOR. THE MOTOR TESTED OK.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 17MMOL/L. IT WAS MENTIONED THAT THE INSULIN PUMP ALARMED MULTIPLE TIMES DURING THE MANUAL PRIME TEST. TROUBLESHOOTING WAS PERFORMED, AND THE DISPLACEMENT TEST COULD NOT BE PERFORMED DUE TO THE MOTOR ERROR ALARMS. IT WAS STATED THAT THE CUSTOMER EXPERIENCED NAUSEA, INCOHERENCE, AND KETONES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9177 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization