BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3920056 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86521
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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. 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.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO THE FLUSH/LOOSE DRIVE SUPPORT DISK. NO ERROR ALARM NOTED. THE DEVICE WAS RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, RESERVOIR TUBE LIP, BELT CLIP SLOT, RESERVOIR TUBE, MINOR SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING AN ALARM ON THE INSULIN PUMP AND INSULIN SQUIRTING OUT DURING MANUAL PRIMING. THE BLOOD GLUCOSE WAS 137 MG/DL. UPON INSPECTION THE CUSTOMER NOTICED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND TO REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396741 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR