BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3150885 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-94469
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 19, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAVE NO BLACK BLOTCHES ON DISPLAY OR DAMAGE ON THE GLASS. THE DEVICE PASSED THE DISPLACEMENT, SELF, REWIND, AND BASIC OCCLUSION TEST. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATIONS. HOWEVER, THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. THE INSULIN PUMP HAD A SEVERELY SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE FELL OUT OF THE BED ON TOP OF THE INSULIN PUMP AND THE DISPLAY GLASS HAD BLACK BLOTCHES ON IT. THE BLOOD GLUCOSE READING WAS 75MG/DL. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CUSTOMER TO RUN THE SELF TEST AND NO MISSING SEGMENTS NOTED. AFTER RECEIVING THE TUBING CLAMP THE CUSTOMER CALLED BACK TO PERFORM THE HIGH PRESSURE TEST AND THE TEST FAILED TWICE. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249992 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR