Model Number MMT-1711H |
Device Problems
Bent (1059); Partial Blockage (1065); Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)
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Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930); Swelling (2091)
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Event Date 05/03/2017 |
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.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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Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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It was reported via phone call that the insulin pump had an error on the insulin delivery.They performed a self-test and it said hardware low level failure.They did an insulin pump reset and got another alarm.The customer's blood glucose level was high so they gave an injection to correct.The customer's blood glucose level was 10.3 mmol/l.It was noted that they received multiple insulin flow blocked alarms.Troubleshooting was performed.When they removed the cannula, there was swelling and pus on the site.The cannula was also bent.It was noted that they did not clean the site before insertion.They would often get infected and have scar tissues.They were advised to speak to their health care professional regarding the sets and sites.The device will not be returned for analysis.
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Search Alerts/Recalls
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