(b)(4).Customer returned pump for alleged labeling anomaly and cosmetic damage located at the keypad overlay found on (b)(6) 2022.The pump passed the displacement test and p-cap locks properly into the reservoir compartment, however, damage to the retainer ring was noted during visual inspection.The following were noted during visual inspection: cracked keypad overlay, stained keypad overlay, pillowing keypad overlay, keypad overlay texture damage, label damage (serial number label faded, stained and peeling), end cap address label missing and cracked retainer.Labeling anomaly confirmed on the serial number label.Cosmetic damage was confirmed at the keypad overlay.The insulin pump involved in this event is the ngp 640g insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin pump, which is marketed in the united states.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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Information received by medtronic indicated that insulin pump sticker was not readable.Customer reported that device labels, including serial number and dome label stickers was missing, removed, worn, faded, or damaged following usage.No harm requiring medical intervention was reported.The insulin pump was returned for analysis.
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