BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3191827 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95134
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO ALARMS NOTED. THE INSULIN PUMP PASSED DISPLACEMENT TEST. UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW AND CRACKED CASE AT DISPLAY WINDOW CORNER.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 299MG/DL. THE CALLER STATED THAT THE INSULIN PUMP ALARMED, AND THE DRIVE SUPPORT CAP WAS STICKING OUT. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291008 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR