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 Codes	Battery Problem (2885); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
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.The pump passed the active current test, sleep current test, and self test.Unit was monitored and no charge/battery lasts less than expected noted.Successfully downloaded history files and traces using thus software.The power management tool indicated abnormal behavior of the lithium backup battery loaded voltage (loaded vlith) as shown on the power management graph.On adapt, low battery alert (104) was recorded on 10/08/2019 18:51:00.000 and on 10/11/2019 15:01:00.000.Pump properly paired guardian link 3 transmitter.No communication anomaly noted.A calibration value was manually entered, and unit displayed the programmed value properly on the unit's graph.Pump was cut open to perform visual inspection and found¿moisture damage on pcba1 and force sensor.Test p-cap unable to lock in place properly due to retainer ring damage.The following were noted during visual inspection: missing o-ring (reservoir tube), partially broken retainer, cracked reservoir tube lip, broken belt clip rails, pillowing keypad overlay, and scratched case.In summary, customer concern for no communication (unresolved) and charge/battery lasts less than expected not confirmed.Unit passed testing within spec and no unexpected alarms were noted.Communication between pump and transmitter was successful.Moisture damage confirmed.Select patient information cannot be provided due to regional privacy regulations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported to medtronic minimed that the customer experienced low battery.The customer reported no adverse event.The event involved product(s) mmt-1780kpk.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer will discontinue the use of the device.Mmt-1780kpk was requested for return and the customer has returned the device.

• 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: lusine boyadzhyan ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 20681710
• Report Number: 2032227-2024-269086
• Device Sequence Number: 12567085
• Product Code: OZP
• UDI-Device Identifier: 00763000190460
• UDI-Public: (01)00763000190460
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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
• Device Lot Number: HG30G4H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2018
• 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
• 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 Age: 49 YR
• Patient Sex: Unknown