The customer reported via phone call that they were hospitalized due to diabetic ketoacidosis and hyperglycemia on (b)(6) 2020.The customer's blood glucose level at the time of the incident was 420 mg/dl.Customer was in the intensive care unit and treated with intravenous insulin drip and insulin syringes.The customer experienced symptoms such as nausea, vomiting, diarrhea, shortness of breath, dehydration.Based on the customer report customer did not allege the pump was under-delivering.The customer reported that the insulin pump had stuck button alarms.The customer said that the reason for the diabetic ketoacidosis was because of the crimped infusion set cannula.The insulin pump will be returned for analysis.
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Device passed the functional tests, 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 delivery accuracy test.All buttons functioning properly.No damage in the keypad assembly and the keypad connector on electrical board was locked properly during visual inspection.Device received with scratched case, pillowing keypad overlay and cracked case corner of the belt clip rails near the battery compartment.(b)(4).
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