BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3990334 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91283
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    INSULIN PUMP WAS RECEIVED WITH A PRIME ALARM DURING BASIC OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED AND LOOSE DRIVE SUPPORT DISK. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN ALARM ON THE INSULIN PUMP, INDICATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR DURING SEATING. THE PATIENT'S BLOOD GLUCOSE WAS 182 MG/DL. IT WAS ADVISED THAT THE CUSTOMER DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463394 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR