BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4190965 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41202
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AND WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A PROTRUDED AND LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS. NO DAMAGE WAS FOUND ON THE ISOLATION TAPE. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, A CRACKED BELT CLIP SLOT, A MISSING END CAP STICKER AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP FELL OFF THE COUNTER AND ALARMED COMPROMISED FORCE SENSOR SYSTEM. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 9.90 MMOL/L. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER MENTIONED ALSO THAT THE INSULIN PUMP HAD BEEN MISSING THE DOME STICKER FOR QUITE SOMETIME. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669032 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CMS

    Patients

    Seq Age Sex Outcome Treatment
    1