BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4820222 · Received June 4, 2015

    Report

    Report Number
    3004209178-2015-62777
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. 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

    THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. THE DEVICE HAD CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE LCD WINDOW, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY RECEIVED A LOW BATTERY ALARM. THE BLOOD GLUCOSE READING WAS 313 MG/DL. THE INSULIN PUMP WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361159 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 49 YR