BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4243737 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50418
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED AND LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SHE IS UNABLE TO COMPLETE THE PRIME PROCESS. CUSTOMER STATED THAT THE SHE CHANGED THE RESERVOIR AND WHEN HOLDING THE ACT BUTTON IT DOESN'T STOP. CUSTOMER REWOUND 3 TIMES THE INSULIN PUMP AND IS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED INSULIN IS SQUIRTING OUT DURING THE MANUAL PRIME. CUSTOMER WAS INSTRUCTED TO HOLD DOWN THE ACT BUTTON UNTIL THEY RECEIVE A SECOND SERIES OF BEEPS OR NUMBERS APPEAR ON THE DISPLAY; CUSTOMER RECEIVED A SECOND SERIES OF BEEPS. BLOOD GLUCOSE VALUE IS 90 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727404 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