Model Number MMT-1782K |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Hypoglycemia (1912)
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Event Date 06/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 that the customer was in emergency room and then hospitalized due to low blood glucose on (b)(6) 2020 with blood glucose of 2.1 mmol/l.Customer reported that the retainer ring was broken.Customer reported that auto mode feature was not active at time of low blood glucose event.The customer was treated with intravenous drip and emergency medical service stayed at home with customer.The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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Failure analysis was originally performed under mdr number 2032227-2020-139785 pump was received with missing reservoir retainer.The p-cap does not lock properly into place.Unable to perform displacement test and reservoir unable to lock into place due to missing reservoir retainer.(b)(4).
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Manufacturer Narrative
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The information provided that the event date with the initial report was incorrect.The correct information has been included with this report.(b)(4).
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Manufacturer Narrative
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The information related to hospitalization provided in initial report was incorrect.The correct information has been provided in this report.(b)(4).
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Event Description
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It was reported that the customer received emergency medical service due to low blood glucose on (b)(6) 2020 with blood glucose of 2.1 mmol/l.
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Search Alerts/Recalls
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