Retainer ring = clear.Customer returned pump for an alleged cosmetic damage located at the retainer ring and battery compartment, possible under delivery, ems dispatched, visit to emergency room and was hospitalized for high bgs and dka found on (b)(6) 2022.Also on, case- (b)(4), svn#: (b)(6) - customer returned pump for an alleged blank display found on (b)(6) 2022 and on case-(b)(4), svn#: (b)(6) - customer returned pump for an alleged was hospitalized for high bgs found on (b)(6) 2018.Device was received with a cracked battery tube threads, a cracked case behind the pump near the battery tube compartment, a partially broken retainer and a cracked retainer.Device powered up properly after battery installation.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 at 0.08710 inches.Device was monitored for several hours and no blank display noted.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.In further full review of the pump history/traces on the event date of march 19, 2022, there were no unexpected alarms/suspends and no bolus recorded dailytotalofbolusinsulindelivered = 0.Device was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts (at quick bolus speed) and were properly recorded in the daily history.No bolus delivery anomaly or history anomaly noted.No under delivery anomaly or over delivery anomaly noted during testing.Power management graph was successfully generated.The power management tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within specification range.No alarms/alerts noted during the testing.However, low battery alert was recorded and found in the formatted history file on: 01/01/2022 04:49:00.000, replace battery alert was recorded and found in the formatted history file on: 01/01/2022 04:49:00.000, 01/01/2022 05:43:01.000 replace battery now alarm was recorded and found in the formatted history file on: 01/01/2022 05:57:00.000 01/01/2022 06:07:00.000 and power loss alarm was recorded and found in the formatted history file on: 01/01/2022 06:07:00.000.Earliest power data available per the power management tool/detail trace file is on 3/4/2022 10:31:00 pm.There was no power data available for the event date of jan 01, 2022.Unable to check power data for low battery alert, replace battery alert, replace battery now alarm and power loss alarm.Device was cut open to perform visual inspection and it was verified that the battery tube power connector is properly connected to j7/pcb1.However, slight corrosion was found on the electronic assembly.No corrosion or moisture damage found on the force sensor, motor and vibrator assembly noted.Force sensor zero offset within specification (21.5 mv).The motor was tested outside of the device on the ngp stb3 and passed.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: a stained keypad overlay, a pillowing keypad overlay and a scratched case.A partially broken retainer and a cracked retainer were confirmed.Cosmetic damage was confirmed at the battery compartment.Blank display was not confirmed.The pump passed all the required testing.Unable to verify customer alleged for high bgs and dka.The force sensor is within specification and the motor functioning properly.Customer alleged for possible under delivery was not confirmed.However, during visual inspection, slight corrosion was found on the electronic assembly.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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