BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3945225 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04610
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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. 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

    NO BUTTON ERROR ALARM NOTED ON INSULIN PUMP. NO INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCH ON LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A BUTTON ERROR ALARM DURING A BOLUS DELIVERY. THE REPORTED BG AT THE TIME OF THE CALL WAS 112 MG/DL. THE PATIENT STATED THAT HE HAD BEEN WORKING OUTSIDE, BUT HE DIDN'T FEEL THAT HE PERSPIRED ON IT. ADVISED THE PATIENT THAT THE PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422648 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR