MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1760KPK 670G PATHWAY BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1760KPK
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Difficult to Program or Calibrate (1496); Loss of Data (2903); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Information received by medtronic indicated that insulin pump had multiple insulin pump error alarms.The customer stated that insulin pump display was blank and frozen.Customer was not able to clear the alarm.Buttons were not responding as well.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
S/w version 4.11e.Retainer ring = black.Pump case = ngp.Customer returned pump for an alleged pump error 23, pump error 49, pump error 68 and unresponsive keypad found on (b)(6) 2020.Pump passed the displacement test, sleep current test, active current test, and self test.Test p-cap locked into the reservoir tube successfully.All buttons function properly.No unexpected pump error 23, pump error 49, or pump error 68 alarms noted during testing.Pump successfully downloaded to thump.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.No unexpected pump error 23, pump error 49, or pump error 68 alarms were noted in the history files on the event date.The pump was cut open for visual inspection and found evidence of moisture on pcba 1.The j1 connector on pcba 1 was locked properly during visual inspection.The following were noted during visual inspection: stained keypad overlay, pillowing keypad overlay, label damage (stained).Pump error 23, pump error 49, and pump error 68 not confirmed during testing.Keypad buttons functioned properly during analysis and passed all required testing.Unresponsive keypad was not confirmed.Pump exposed to moisture confirmed on pcba 1.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: KIT MMT-1760KPK 670G PATHWAY BLACK MG
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 10263287
• Report Number: 2032227-2020-145503
• Device Sequence Number: 2888667
• Product Code: OZP
• UDI-Device Identifier: 00763000283445
• UDI-Public: (01)00763000283445
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

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-1760KPK
• Device Catalogue Number: MMT-1760KPK
• Device Lot Number: HG3ZW3A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2020
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown