The customer reported via phone call that they experienced low blood glucose.Blood glucose reading was 30mg/dl.Current blood glucose reported at the time of call was 132 mg/dl.Customer was treated with treated with food and glucose tablets for their low blood glucose.Customer had a symptoms like shaking, anxiety, sweating, confusion, fatigue, belligerence inability.Customer stated that they had been experiencing unexpected low blood glucose level form last 2 months.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The device will be returned for analysis.Frn-mmt-332a-rsvr,unomed-set.
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Retainer ring = clear.On (b)(6) 2021 the customer alleged was for low bgs and cosmetic damage located at the serial label sticker.On (b)(4) (b)(6) 2021, the customer alleged was for low bgs.The test p-cap locks properly in place in the reservoir compartment noted.Device received with pillowing keypad overlay and stained serial number label sticker during the visual inspection.Device passed the rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test.Device was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured (23.2 mv).The motor was tested outside of the device on the ngp stb3 and passed.In summary, insulin pump passed all required testing.Unable to verify customer alleged for low bgs.The force sensor is within specification and the motor functioning properly.Cosmetic damage was confirmed at the serial number label sticker.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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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