BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182757 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39943
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED FAILED BATTERY TEST AFTER BATTERY INSTALLATION DUE TO CORRODED BATTERY TUBE. OFF NO POWER ALARM NOT VERIFIED DUE TO FAILED BATTERY TEST ALARM. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED FAILED BATTERY TEST AFTER BATTERY INSTALLATION DUE TO CORRODED BATTERY TUBE. OFF NO POWER ALARM NOT VERIFIED DUE TO FAILED BATTERY TEST ALARM. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND MISSING END CAP STICKER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD NO POWER AND THAT THE CUSTOMER HAD TRIED 10 NEW BATTERIES UNSUCCESSFULLY. THE BLOOD GLUCOSE READING WAS 230 MG/DL. THE CUSTOMER STATED THAT THERE WAS A SOLID CIRCLE ON THE INSULIN PUMP, AND THE BATTERY SYMBOL WAS PRESENT BUT EMPTY. SHE NOTED THAT SHE DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. DURING A SELF TEST ATTEMPT, THE CUSTOMER REPORTED THAT THE DEVICE COUNTED TO 4, THEN SHUT OFF. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661507 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR