BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4143757 · Received October 6, 2014

    Report

    Report Number
    2032227-2014-32021
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, MISSING END CAP STICKER AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED. THE DEVICE PUMP PASSED THE FUNCTIONAL TESTING INCLUDING THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. THE UNIT WAS MONITORED FOR TWO DAYS WITH 4.0 U/H BASAL. THE BASAL DELIVERED PROPERLY AND THE DEVICE RECORDED PROPERLY IN DAILY TOTALS. NO BASAL ANOMALY NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP HAS BEEN FAILING INTERMITTENTLY AND OFTEN FIVES BASAL DOSE HALF WAY THROUGH. IT WAS ALSO REPORTED THE CUSTOMER HAS PREVIOUSLY HAD PROBLEMS WITH BATTERIES NOT LASTING VERY LONG AND WERE GIVEN A NEW BATTERY LID A WEEK AGO. CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 25MMOL/L. CUSTOMER CONTINUOUSLY HAS HIGH BLOOD GLUCOSE OVER 20MMOL/L. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 11MMOL/L. HAS HAD ISSUES WITH THE INSULIN PUMP SINCE (B)(6). NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623701 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1