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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2020
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.Pump was received with a critical pump error (open book image) alarm.Unable to perform the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement test, active current measurement test and self test due to critical pump error (open book image) alarm.Pump was cut open to perform visual inspection and found moisture damage on the force sensor.Force sensor zero offset within specification (22.76 mv).Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: faded serial number label, cracked battery tube threads, cracked case at corner of the belt clip rails, cracked case along the side of the battery tube and cracked retainer ring.Critical pump error (open book image) alarm confirmed due to moisture damage on the force sensor.Cosmetic damage confirmed at the battery compartment.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 reported pump had a crack the customer reported no adverse event.The event involved product(s) mmt-1780kpk.Troubleshooting was performed.No harm requiring medical intervention was reported.Mmt-1780kpkwas requested and customer response was the device will be returned.

• 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: 20661840
• Report Number: 2032227-2024-267321
• Device Sequence Number: 7211202
• Product Code: OZP
• UDI-Device Identifier: 00763000190460
• UDI-Public: (01)00763000190460(17)211209
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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 Expiration Date: 12/09/2021
• Device Model Number: MMT-1780KPK
• Device Catalogue Number: MMT-1780KPK
• Device Lot Number: HG30XRM
• 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: 10/17/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2018
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 105 KG