MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KL

Device Problems Mechanical Problem (1384); Priming Problem (4040)

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

Event Date 11/18/2021

Event Type  malfunction  

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.

Event Description

Information received by medtronic indicated that the insulin pump was not rewinding since a couple of days.Troubleshooting was performed and the insulin pump did not show complete status.Customer was unable to exit the load reservoir process.Piston was not moving.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

Manufacturer Narrative

Retainer ring = black.On (b)(6) 2021 the customer reported that the unit is not rewinding.Inserted a test p-cap into the retainer ring, and it locked in place properly.Did not note any cracks in or around the reservoir tube lip, or in the retainer ring.Furthermore, the retainer ring is solidly attached to the reservoir tube lip.Did not note any cracks in the battery tube or in the battery threads.Initially the unit passed self test; then it failed rewind test.During motor rewind, the motor slide within the reservoir compartment did not go down whatsoever.No alert/error messages were noted.Unable to perform the displacement prime/seating, basic occlusion, force sensor and occlusion tests due to the motor failure.Eventually a constant red notification light came on and an unexpected open book occurred afterwards.Initially thus software was utilized and uploaded trace/history files properly.After the open book occurred, unable to download/upload using crest/thus.Using the data that was previously uploaded before the open book occurred, the adapt tool did not list any pump errors which could potentially trigger an open book.The case was cut open.After visual inspection, did not note any signs of previous moisture presence or corrosion inside the battery compartment or on any of the boards, assemblies, and the motor inside the unit.After plugging a known good pcba2 and a known good pcba1 into the original case, the unit booted up normally.After plugging a known good pcba2 into the original pcba1 and then into the original case, the unit booted up normally again.But after plugging the original pcba2 into a known good pcba1 and then into the original case, the unit booted up to a critical pump error (open book image) alarm.The force sensor zero offset measured within spec = 23.3 mv.Finally the motor was tested outside the unit, and it passed.In summary, the customer¿s report that the unit is not rewinding was confirmed during testing.The rewind anomaly as well as the open book is due to a problem that was isolated to pcba2.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: 630G INSULIN PUMP MMT-1715KL 630G
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 12906306
• MDR Text Key: 283779544
• Report Number: 2032227-2021-224702
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)231118
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/18/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4VKH9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 64 KG