Model Number MMT-1715K |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Coma (2417)
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Event Date 03/18/2018 |
Event Type
Death
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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 via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2017.The cause of death was a seizure attack and a diabetic coma.The caller stated that they did not know if the customer had any other illnesses that may have led to the customer's passing.The customer¿s blood glucose was 26 mg/dl at the time of admission.The customer was not wearing the insulin pump at the time of death.The insulin pump had been disconnected more than 48 hours prior to passing, at the time of admission.The caller stated the customer was taken off the pump and put on intravenous insulin.The customer was not using sensors.The customer went to sleep on (b)(6) 2017 and never woke up again.The caller declined to return the insulin pump for analysis.
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Manufacturer Narrative
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The information related to date of hospitalization and date of passing provided with initial report was incorrect.(b)(4).
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Event Description
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The correct date of hospitalization is (b)(6) 2018 and customer passing was on (b)(6) 2018.The customer went to sleep on march 17, 2018 and never woke up again.
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Search Alerts/Recalls
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