BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972081 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05100
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 11, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    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

    CUSTOMER CALLED STATING HIS INSULIN PUMP HAD SEVERAL NO DELIVERY ALARMS DURING PRIME LAST MONTH. HIS BLOOD GLUCOSE IS 336 MG/DL, AND HE TREATED WITH A BOLUS. DURING TROUBLE SHOOTING, INSULIN EXITED THE TUBING DURING A FIXED PRIME. THE CANNULA WAS NOT BENT, BUT CUSTOMER SAID IT WAS SLIGHTLY CURVED. THE DEVICE HISTORY SHOWED MULTIPLE ALARMS, INCLUDING LOW RESERVOIR AND NO DELIVERY. A TEMPORARY BASAL WAS NOT PROGRAMMED BEFORE THE ALARM. THE DEVICE WAS NOT STORED FOR A LONG TIME. THE ALARM OCCURRED DURING NORMAL USE. A BOLUS DELIVERY WAS ACCURATELY RECORDED IN THE HISTORY. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447280 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR