BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3854479 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85319
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME THE INSULIN PUMP DURING THE PRIME TEST DUE TO A LOOSE/FLUSH DRIVE SUPPORT DISK. A CRACKED BATTERY TUBE THREADS AND SCRATCHED LCD WINDOW ALSO NOTED.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING THE PRIME PROCESS HE IS RECEIVING A PRIME/DELIVERY ALARM ON HIS INSULIN PUMP, HE CANNOT EXIT FROM THE PREPARING TO PRIME MODE AND INSULIN WOULD NOT STOP DRIPPING. CUSTOMER STATED THAT THE REWIND MESSAGE APPEARED AFTER THE ALARM ALERT AND CONFIRMED THAT THE DRIVE SUPPORT CAP IS PROTRUDED. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME IS 211GM/DL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332155 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 14 YR