BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2761217 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-89713
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 14, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

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

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WAS HOSPITALIZED DUE DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 376MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE INSULIN PUMP ALARMED SEVERAL ALARMS. REVIEWED THE ALARM HISTORY AND FOUND AUTO OFF AND OFF NO POWER ALARMS. THE BASALS WERE CORRECT. THE PRIME HISTORY SHOWS THAT THE CUSTOMER WAS NOT CHANGING THE INFUSION SETS EVERY TWO TO THREE DAYS. THE MOTHER ALSO MENTIONED THAT THE CUSTOMER WAS NOT BOLUSING FOR SOME REASON, AND THE BLOOD GLUCOSE METER WAS NOT SENDING OVER THE READINGS TO HER INSULIN PUMP. THE CALLER STATED THAT THE INSULIN PUMP HAS CRACKS NEAR THE BUTTONS. ADVISED THAT THE DEVICE WILL BE REPLACED AND REVERT TO BACK UP PLAN. 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-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization