BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142120 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33144
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    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 WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A LOOSE AND PROTRUDED DRIVE SUPPORT DISK. NO ALARM WAS NOTED FOR A COMPROMISED FORCE SENSOR SYSTEM. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD AN ERROR ALARM DURING THE MANUAL PRIME. THE DRIVE SUPPORT CAP WAS NOTED TO BE STICKING OUT. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 176 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621321 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR