MAUDE Adverse Event Report: MEDTRONIC MINIMED 670G INSULIN PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number	MMT-1780KCO
Medical Device Problem Codes	Break (1069); Crack (1135); Structural Problem (2506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insulin pump was received with broken belt clip rail.The pump was received with cracked keypad overlay at select button, minor scratched lcd window, case and keypad overlay.No cracks were noted at the display window.The pump was received with loose / detached retainer ring.
Event or Problem Description
It was reported of damage from the insulin pump.The customer's blood glucose reading was unknown.Customer reported that the pump is broken in the insulin compartment.The customer mentioned that the pump fell and the screen is cracked.Customer will return the pump for analysis.
Additional Manufacturer Narrative
The information provided was incorrect with the initial report.The correct information has been provided with this report.
Additional Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0956-2020 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.

• Brand Name: 670G INSULIN PUMP
• Common Device Name: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6049197
• Report Number: 2032227-2016-34223
• Device Sequence Number: 3457613
• Product Code: OZP
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-1780KCO
• Device Catalogue Number: MMT-1780KCO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: 03/15/2021; 10/14/2019
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 03/15/2021; 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0956-2020
• Patient Sequence Number: 1
• Patient Sex: Unknown