It was reported that the customer passed away in hospice care.The customer was hospitalized on (b)(6) 2018.The cause of death was lung cancer.The caller did not state whether the customer had any other illnesses that may have led to the customer's passing.The customer¿s blood glucose was 216 mg/dl at the time of admission, and 83 mg/dl at the time of passing.The customer was wearing the insulin pump at the time of death.The caller mentioned death following loss of consciousness and the customer being found on the floor with diabetic ketoacidosis, a coma or other complications.The caller also stated the customer had been given glucagon due to a low.The customer was using sensors.The caller did not state whether they would return the insulin pump for analysis.Updated summary: pump upload revealed a lot of suspend before low alerts that the customer did not respond to.Correction: the blood glucose of 83mg/dl was in the last moments prior to passing but not the last blood glucose.
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"this report is part of a retrospective review and remediation efforts in response to a warning letter.(b)(4).S/w 4.10d.The unit did not have a battery installed when received.Unit passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and the dat test at 0.08730 inches.Unit had minor scratched display window, scratched case, pillowing keypad overlay and cracked retainer.Data analysis (date of death: (b)(6) 2018).On (b)(6) 2018 dailytotalofallinsulindelivered = 15.45.On (b)(6) 2018 dailytotalofallinsulindelivered = 15.3.On (b)(6) 2018 dailytotalofallinsulindelivered = 12.275.On (b)(6) 2018 dailytotalofallinsulindelivered = 12.7.On (b)(6) 2018 dailytotalofallinsulindelivered = 14.425.On (b)(6) 2018 dailytotalofallinsulindelivered = 12.275.On (b)(6) 2018 dailytotalofallinsulindelivered = 8.
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