BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4111452 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27999
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE BASIC OCCLUSION TEST AND THE DISPLACEMENT TEST. NO MOTOR ERROR ALARMS WERE NOTED. HOWEVER, THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP WAS ALSO RECEIVED WITH SOME COSMETIC DAMAGE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S SENSOR INSULIN PUMP DISPLAYED A MOTOR ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLE SHOOTING WAS CONDUCTED AND WE EXPLAINED THE POSSIBLE CAUSES FOR THE ALARM. DEVICE IS BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590122 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR