MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1780KPK 670G PATHWAY BLACK MG; AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1780KPK
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received by medtronic indicated that the customer reported insulin flow blocked alarm during fill tubing.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer will discontinue using the device and the insulin pump will be returned for analysis.
Additional Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Unable to perform the self-test, displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test and occlusion test due to insulin flow blocked alarm during priming at 08/01/23 at 07:50 am isolated to pcb1 and pcb2.Unit successfully downloaded to thus.Confirmed pump alarmed insulin flow blocked alarm on 07/21/2020 23:55:27.000 in pump downloaded history.The electronic assemblies and motor assemblies were inspected, and no anomalies noted.The following were noted during visual inspection: scratched case, and pillowing keypad overlay.Pump did not pass testing isolated to pcb1 and pcb2.Confirmed insulin flow block alarm during testing and in pump downloaded history.Patient information cannot be provided due to regional privacy regulations.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: PUMP MMT-1780KPK 670G PATHWAY BLACK MG
• Common Device Name: AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: justin ellis ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635265677
• MDR Report Key: 17593967
• Report Number: 2032227-2023-258741
• Device Sequence Number: 12828828
• Product Code: OZP
• UDI-Device Identifier: 00763000283520
• UDI-Public: (01)00763000283520
• Combination Product (Y/N): N
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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-1780KPK
• Device Catalogue Number: MMT-1780KPK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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: A
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Unknown