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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Date 03/30/2021

Event Type  malfunction  

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.Select patient information cannot be provided due to regional privacy regulations.Unit came in with detached retainer ring critical pump error alarm (open book).Unable to lock into p-cap properly during testing.Successfully utilized crest and thus to download history files and traces.Unable to perform the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, and displacement test due to critical pump error (open book).The adapt tool was utilized to search for alarms that may have occurred in the past or during complain call that might of trigger the reason complain.The long trace history file revealed no delivery alarms and pump error 63.It revealed several no delivery from 03/27/2021 through 03/30/2021 a total of 18 were recorded.Pump error 63 (variable info = 12, file number = 522 and line = 341) was triggered twice on 4/4/2021 at 7:04:48 and 07:04:52.Per software engineer log it was determined the pump error 63 was due to hardware watchdog.Isolate to electronic assembly.Proceeded by cutting unit open and perform a visual inspection of connectors and electronic assemblies.No moisture damage noted during visual inspection.Force sensor zero offset within spec (23 mv).Unit also received with detached retainer, missing o-ring (reservoir tube), cracked keypad overlay, stained keypad overlay, missing display window/cover, scratched case and reservoir tube cracked.In conclusion, unable to confirm customer concerns for high bg and under delivery due to critical pump error (open book image).Critical pump error was confirmed due to pump error 63.Pump error 63 was confirmed due to hardware issue.Problem isolated to electronic assembly.Retainer ring damage and unable to lock into place confirmed due to detached retainer ring.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.

Event Description

Information received by medtronic indicated that customer reported physical damage to the pump.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer discontinued using the device and device was returned for analysis.

• 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: 18823938
• MDR Text Key: 337743015
• Report Number: 2032227-2024-135205
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000192143
• UDI-Public: (01)000000763000192143
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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: 01/23/2024
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2019
• 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
• Patient Age: 58 YR