BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2830885 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-90708
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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 DUE TO KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 30MMOL/L. THE CUSTOMER'S BLOOD GLUCOSE WAS TREATED WITH THE INSULIN PUMP AND MANUAL DAILY INJECTIONS. THE CUSTOMER HAD BEEN VOMITING DURING THE NIGHT, BUT THE INFUSION SET OR RESERVOIR WAS NOT CHANGED. WHILE THE CUSTOMER WAS ADMITTED IN THE HOSPITAL IT WAS FOUND THAT THE INSULIN PUMP IS WORN OUT AND HAD CRACKS AROUND THE BATTERY COMPARTMENT. THE CANNULA WAS REMOVED AND NOTICED THAT THE CANNULA WAS BENT IN A 90 DEGREES ANGLE. THE PROGRAMMING IN THE DEVICE WAS CORRECT. IT WAS MENTIONED THAT THE INFUSION SET AND RESERVOIR WERE THROWN AWAY WHEN THE CUSTOMER WENT TO THE HOSPITAL. ADVISED THE CALLER THAT THE INSULIN WOULD BE REPLACED. 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-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization UNOMEDICAL DEVICES