MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number MMT-1715KL

Device Problems Device Alarm System (1012); Mechanical Problem (1384); Obstruction of Flow (2423); Power Problem (3010); Priming Problem (4040)

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

Event Date 05/04/2023

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.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

Information received by medtronic indicated that the customer reported rejected new battery, unexplained alarm, failed rewind/prime, and trouble hearing alarms. troubleshooting was not performed. no harm requiring medical intervention was reported. it was unknown whether the customer will continue to use the device.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Cancel and close.S/w version 4.11 c.Retainer ring = black.Case type = ngp ¿.Customer returned pump for alleged audio/vibrate anomaly/absence of alarm/prime/fill anomaly/rewind anomaly/no delivery/occlusion alarm/failed batt test alarm found on (b)(6) 2023.Pump passed the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test.No unexpected no delivery/occlusion alarm, no unexpected no delivery/occlusion alarm, failed batt test alarm, prime/fill anomaly/rewind anomaly noted during testing.The alarms/alerts functioned properly.Thus and carelink software was utilized and downloaded trace/history files properly.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.No unexpected no delivery alarm or failed battery test alarm found in the pump history file/trace on the event date 04-may-2023.Pump was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured (23.1 mv).The motor was tested outside of the device on the ngp stb3 and passed.¿test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: cracked case along the side of the battery tube and pillowing keypad overlay.In summary, pump passed all required testing.Audio/vibrate anomaly/absence of alarm, prime/fill anomaly, rewind anomaly, no delivery/occlusion alarm and failed batt test alarm was not confirmed.Cosmetic damage found on the pump case.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: AUTOMATED INSULIN DOSING, 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: justin ellis ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635265677
• MDR Report Key: 16972403
• MDR Text Key: 315651774
• Report Number: 2032227-2023-208950
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)240510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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 Expiration Date: 05/10/2024
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5ATWY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 84 KG