BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3982306 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06149
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD BROKEN RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED DISPLAY WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR WINDOW, MISSING END CAP STICKER AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS. NO BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 305 MG/DL. CUSTOMER TREATED WITH THE INSULIN PUMP. CUSTOMER STATED THAT SHE HAD DROPPED THE INSULIN PUMP A COUPLE OF DAYS PRIOR. SHE ALSO STATED THAT SHE HAD STARTED TO HOLD THE INSULIN PUMP WITH THE BUTTONS FACING HER BODY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456792 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR