Model Number MMT-751NAS |
Device Problems
Leak/Splash (1354); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)
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Patient Problems
Hyperglycemia (1905); Overdose (1988)
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Event Date 06/17/2015 |
Event Type
malfunction
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Event Description
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The customer reported via phone call that she was trying to give a bolus and it never stopped.Customer pulled the set out of her body and was receiving error messages while it was releasing insulin.Customer stated that the battery had been pulled.Customer's blood glucose was 175 mg/dl at the time of the incident.Customer received a failed battery test and now the pump is empty.Customer's current blood glucose is also 175 mg/dl.Customer stated that none of the buttons worked and she had a delivery anomaly.Customer mentioned that the doctor assisted with programming her pump.Customer removed the pump.Customer stated that the numbers are going up on the pump but she did not receive a button error.Customer was advised that the pump will need to be replaced.Customer was also advised to discontinue use of the pump and revert to a back-up plan.
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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.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.
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Manufacturer Narrative
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The insulin pump was received with corroded keypad traces.All of the buttons functioned properly.The operating currents are normal, no unexpected failed battery test alarm and no unexpected numbers ramping during our testing.Testing of the insulin pump showed that it was functioning properly and passed all functional testing.The insulin pump has cracked case at the display window corner, cracked reservoir tube lip and minor scratched lcd window.
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Search Alerts/Recalls
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