BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4182600 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39855
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A CONSTANT MOTOR ERROR ALARM DURING THE REWIND DUE TO A CORRODED MOTOR HOME SWITCH. NO MOTOR POSITION ENCODER ERROR ALARM COULD BE VERIFIED AND THE FUNCTIONAL TESTING COULD NOT BE COMPLETED DUE TO THE MOTOR ERROR ALARM. THE INSULIN PUMP HAD MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS INSULIN PUMP ALARMED AND THEN HE RECEIVED A MOTOR ERROR ALARM DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE WAS 187 MG/DL. CUSTOMER STATED THE DEVICE GOT WET OVER A MONTH AND A HALF AGO WHEN HE RAN IN THE OCEAN. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE ALARM WAS CLEARED. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER IS ABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660258 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 48 YR