BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110616 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27449
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    ALL OPERATING CURRENTS ARE WITHIN THE SPECIFICATION, NO UNEXPECTED LOW BATTERY, OFF NO POWER ALARM OR BATTERY INDICATOR ANOMALY NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED OFF NO POWER WITHOUT A LOW BATTERY ALERT PRIOR TO THE ALARM. THE BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER STATED THAT FOR THE PAST 2 WEEKS, THE INSULIN PUMP DRAINED THE BATTERIES QUICKLY. HE NOTED THAT WITHIN A FEW DAYS OF REPLACING THE BATTERY, THE INSULIN PUMP ALERTED LOW BATTERY, THEN OFF NO POWER. HOWEVER, THERE WERE SEVERAL TIMES IN THE HISTORY WHERE THE LOW BATTERY ALERT WAS MISSING. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590581 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR