MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712K

Device Problems Break (1069); Moisture or Humidity Problem (2986)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2023

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported the presence of water inside the pump following water exposure, used a silicon case, but identified a crack on the back of the pump.No harm requiring medical intervention was reported.Troubleshooting was partially performed.The customer will discontinue the use of the insulin pump.The insulin pump will be returned for analysis.

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 was received with a critical pump error (open book image) alarm after battery installation.Unable to perform the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test, and dat test due to the critical pump error (open book image) alarm.Successfully utilized crest and thus to download history files, traces, and comlink3 files.A review of the pump history file reveals on 1/11/2024 at 09:57 a pump error 35 alarm was triggered which caused the critical pump error (open book image) alarm.The pump was cut open to perform a visual inspection.Moisture damage was found on the electronic assembly (pcba 1 and pcba 2), motor, force sensor, and inside the battery tube.A test p-cap does lock into place inside the reservoir compartment properly.The following were noted during the physical inspection: scratched case, stained serial number label, pillowing keypad overlay, cracked battery compartment at the corner of the belt clip rails, and cracked battery tube threads.Cosmetic damage on the battery compartment and battery tube threads is confirmed.Critical pump error (open book image) and pump error 35 alarms are confirmed due to moisture damage on the force sensor.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.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: 640G INSULIN PUMP MMT-1712K
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 18907329
• MDR Text Key: 337701343
• Report Number: 2032227-2024-142677
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317157
• UDI-Public: (01)000000763000317157
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712K
• Device Catalogue Number: MMT-1712K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1