BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103680 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25418
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    INSULIN PUMP RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER DID NOT KNOW THE BLOOD GLUCOSE READING. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. THE CUSTOMER STATED THAT HE WAS HUNCHED OVER AND MAY HAVE PRESSED THE KEYS INADVERTENTLY. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582141 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR