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 Device Alarm System (1012)

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

Event Date 12/09/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported that the insulin pump had no vibration or tone.No harm requiring medical intervention was reported.Troubleshooting was performed.It was reported that the insulin pump did not vibrate during the vibrate test portion of the self test and performed vibration test, and not passed.The customer will discontinue using the device and it will be returned for analysis.

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.The insulin pump involved in this event is the ngp 640g insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin pump, which is marketed in 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.

Manufacturer Narrative

The pump was received with partially broken reservoir tube lip, missing retainer, and missing reservoir tube o-ring.A test p-cap and reservoir were installed and did not lock in place due to the broken reservoir tube lip and missing retainer.There was no vibration during the self test and unable to perform the displacement test due to the broken reservoir tube lip and missing retainer.Activated and deactivated the vibrate function from the sound and vibration settings menu and the vibrator did not respond.The pump trace and history files were successfully downloaded utilizing thus.The pump was cut open to perform a visual inspection.No evidence of physical damage or moisture damage was found on the electronic assembly (pcba 1 and pcba 2), vibrate harness assembly, motor, or force sensor.Swapped out a test case, powered the pump up, and toggled the vibrate function on and off several times.The pump vibrated properly.No vibrate anomaly is isolated to the vibrate harness assembly.The following were noted during the physical inspection: missing retainer, partially broken reservoir tube lip, scratched case, cracked select button keypad overlay, stained keypad overlay, keypad overlay texture damage, cracked battery tube threads, cracked battery compartment, end cap address label faded, pillowing keypad overlay, and missing reservoir tube o-ring.The vibrator not activating properly anomaly is confirmed, fault isolated to the vibrate harness assembly.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 16046905
• MDR Text Key: 308382085
• Report Number: 2032227-2022-387103
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• 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
• Device Lot Number: HG2KLKQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1