MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1712KL 640G V4.10 BK SF MG; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712KL

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported pump delivered 17 units of bolus which was not initiated by the customer and customer cancelled the current bolus. troubleshooting was not performed.No harm requiring medical intervention was reported.The device will not be returned for failure 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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.The insulin pump involved in this event is the ngp 640g insulin infusion 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

Pump received with a cracked retainer ring.Unit passed active current measurement, sleep current measurement test, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.Unit passed dat test at 0.0873 inches.Pump did not pass the self-test.During the self-test, pump error 63 (variable 3) occurred at 07/05/2023 10:32:49.000.Pump error 53 (esf# (b)(4); file number: 2005; line number: 5632) occurred during test on 07/05/2023 10:34:32.000.Pump error 3 occurred during testing on 07/05/2023 10:35:10.000.No over delivery anomalies noted during testing.Unit successfully downloaded to thus and carelink.Confirmed 61.65 units of normal bolus was delivered on 11-aug-2022 between 06:32:08.000 and 22:33:34.000.Pump was cut to perform visual inspection and found moisture damage on the pcba 1, pcba 2, force sensor and motor home switch.Force sensor zero offset within specification with 22.3mv.The p-cap/reservoir does lock properly, however, a cracked retainer ring was noted during inspection.The following were noted during visual inspection: corroded battery tube, reservoir tube cracked, scratched lcd window (minor), scratched case, overlay scratched, cracked keypad overlay, stained keypad overlay, pillowing keypad overlay, keypad overlay texture damage, damaged display window cover and cracked retainer.No over delivery anomalies noted during testing.Cracked retainer ring damage was confirmed.Pump error 63 (variable 3) was confirmed due to broken trace at u1 pin 6 on the keypad assembly.Pump error 53 was confirmed due to software error.Pump error 3 was confirmed due to pump error 53.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: PUMP MMT-1712KL 640G V4.10 BK SF MG
• 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: 16112993
• MDR Text Key: 308262783
• Report Number: 2032227-2023-103017
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000258344
• UDI-Public: (01)000000763000258344
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/31/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712KL
• Device Catalogue Number: MMT-1712KL
• Device Lot Number: HG3RBR4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/02/2023
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 07/10/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• 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