This report is part of a retrospective review and remediation efforts in response to a warning letter.Correction/removal number: z-0958-2020.(b)(4).S/w 4.11d.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 0.08700 inches.No over delivery anomaly or under delivery anomaly noted.Unit uploaded properly using carelink.Unit was programmed with multiple test boluses.All boluses delivered properly.No bolus anomaly or history anomaly noted.Unit had scratched case, pillowing keypad overlay and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: (b)(6) 2019 daily total of all insulin delivered= 113.125, (b)(6) 2019 daily total of all insulin delivered= 91, (b)(6) 2019 daily total of all insulin delivered= 27.2), (b)(6) 2019 daily total of all insulin delivered= 63.8), (b)(6) 2019 daily total of all insulin delivered= 12.95, (b)(6) 2019 daily total of all insulin delivered= 12.95), (b)(6) 2019 daily total of all insulin delivered= 0, (b)(6) 2019 daily total of all insulin delivered= 0, (b)(6) 2019 daily total of all insulin delivered= 0, (b)(6) 2019 daily total of all insulin delivered= 0, (b)(6) 2019 daily total of all insulin delivered= 0.075, (b)(6) 2019 daily total of all insulin delivered= 0.075), (b)(6) 2019 daily total of all insulin delivered= 0, (b)(6) 2019 daily total of all insulin delivered= 0, (b)(6) 2019 daily total of all insulin delivered = 0, (b)(6) 2019 daily total of all insulin delivered = 0.The formatted history file lists recorded multiple bolus delivered on (b)(6) 2019.(b)(6) 2019 daily total of all insulin delivered = 63.8 units.The customer manually programmed and delivered the boluses listed below.There was low sg while suspend alert on (b)(6) 2019 12:02:38.Customer resumed basal delivery on (b)(6) 2019 12:04:24.(b)(6) 2019 00:06:05 normal bolus programmed = 20.(b)(6) 2019 00:06:22 bolus canceled.(b)(6) 2019 00:06:22 normal bolus programmed = 3.9.(b)(6) 2019 00:07:09 normal bolus programmed = 19.9.(b)(6) 2019 00:08:30 normal bolus delivered = 19.9.(b)(6) 2019 00:09:46 normal bolus programmed = 20.(b)(6) 2019 00:11:09 normal bolus delivered = 20.(b)(6) 2019 00:13:59 normal bolus programmed = 20.(b)(6) 2019 00:15:19 normal bolus delivered = 20.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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