The customer¿s brother reported via phone call that the customer was hospitalized in emergency room for diabetic ketoacidosis and cardiac arrest on (b)(6) 2019.Customer¿s blood glucose level was 313 mg/dl at the time of incident.Customer stated that the insulin pump received a low battery alert prior to the replace battery alert within 8 hours for 2 times.Customer stated that the battery was not previously used and battery cap not loose, cracked or damaged.Customer stated that the insulin pump was not pushing enough insulin in her body.Customer experienced h1n1 fever, shortness of breath and flu like symptoms.Customer was treated with insulin drip.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 or seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08730 inches.However, device trace download analysis confirmed the device alarmed power error 25, power loss alarm, replace battery alert and replace battery now alarm.The power management tool confirmed power error 25, power loss alarm, replace battery alert, replace battery now alarm was triggered when the backup battery loaded voltage was less than 3.5 volts for 4 consecutive hours due to connector resistance electrical board.After disconnecting and reconnecting the internal battery connector on electrical board, the device was monitored and functioned properly.Device received with scratched case, pillowing keypad overlay and minor scratched lcd window.
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