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

Model Number MMT-1715K

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885); Priming Problem (4040)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.(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.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

Medtronic received information that back light anomaly, prime/fill anomaly, charge/battery lasts less than expected occurred.There was no adverse impact or consequence reported as a result of this event.

Manufacturer Narrative

Retainer ring = black customer complaint about prime/fill anomaly alarms, charge battery alarm and back light anomaly on (b)(6) 2021.The pump passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test.And self-test.The pump primed and seated properly when the test reservoir was detected.No prime/fill anomaly noted.All boluses delivered properly and were listed in the daily history.The pump was programmed with multiple basal profiles and monitored.All basal profiles delivered their indicated amounts and were verified in the daily and summary history screens.Successfully downloaded history files using thus software.The power management tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within spec range.Detailed trace analysis did not confirm charge battery alarm was triggered.Backup battery unloaded or loaded voltage (ul vlith) did not drop below 3.5v for consecutive 240 minutes.No unexpected occlusions or delivery anomaly, bolus anomaly or basal anomaly noted on download history file.No unexpected back light anomaly noted.The following were noted during visual inspection cracked case at battery tube case and cracked battery tube threads.The unit p-cap / test reservoir locks in place properly.Unit was not confirmed for prime/fill anomalies, charge battery alarm or back light anomalies.Unit passed all required testing.(b)(4).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-1715K 630G BLACK MG
• 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: 13744726
• MDR Text Key: 297147925
• Report Number: 2032227-2022-127285
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316631
• UDI-Public: (01)000000763000316631
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG451LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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: 51 YR
• Patient Weight: 149 KG