BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141697 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33266
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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 COMPLETE THE PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE MOTOR PASSED MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, BROKEN BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING A PRIMING ATTEMPT. THE BLOOD GLUCOSE READING WAS 111 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621036 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR