Model Number MMT-754CMH |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/13/2015 |
Event Type
malfunction
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Manufacturer Narrative
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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.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
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Event Description
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The customer reported via phone call indicating that the insulin pump alarm button error.Customer's blood glucose was unknown mg/dl.The customer was attempting to use the bolus wizard and found that the numbers continued changing after she released the pump.The customer does not recall any significant event leading to the alarm.The customer was advised to discontinue use of the device and revert to a backup plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.
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Manufacturer Narrative
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No button error alarm was noted.However, the pump had intermittent button response due to moisture damage on the keypad trace.The pump had minor scratched on the lcd window, a cracked case near the display window corners, a broken belt clip slot, and a cracked reservoir tube lip.No numbers ramping up on their own or scroll bar moving with no input noted.
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Search Alerts/Recalls
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