BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4210675 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37281
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP GAVE AN ALARM DURING THE PRIME TEST DUE TO MOISTURE DAMAGE ON THE FORCE SENSOR. THE PUMP ALSO HAD MOISTURE DAMAGE ON THE MOTOR ASSEMBLY. IN ADDITION, THE PUMP HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNER, A CRACKED RESERVOIR TUBE WINDOW, AND CRACKED BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4). 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO WATER WHEN SHE JUMPED INTO A POOL THE WEEK PRIOR. THE BLOOD GLUCOSE READING WAS 354 MG/DL. SHE STATED THAT SHE RECEIVED AN ALARM FOR A LOOSE DRIVE SUPPORT CAP. SHE STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648964 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR