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 No Display/Image (1183); Overheating of Device (1437); Power Problem (3010)

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

Event Date 12/22/2021

Event Type  malfunction  

Event Description

Information received by medtronic stated that customer got new battery cap and then battery was heating and insulin pump was not turning on.Customer stated that the insulin pump had a failed battery alarm.No harm was required during medical intervention.The insulin pump 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.

Manufacturer Narrative

Retainer = black customer returned pump for alleged blank display and battery heating up after receiving a new battery cap and battery failed alarms found on (b)(6) 2021.The pump was received without the original battery cap.Installed a test battery cap and continued testing.The pump powered up properly after battery installation.No blank display noted.The pump passed the sleep current measurement, active current measurement, self test and displacement test.Successfully downloaded the trace and history files using thus.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within spec range.The pump was monitored for two (2) days and no blank display, battery failed alarms, unexpected additional power/battery alerts, or pump/battery heating up/hot to the touch noted.A review of the history files reveals on (b)(6) 2021 there was one (1) low battery alert at 02:06, one (1) change battery fault (replace battery alert) at 11:37, one (1) off no power (replace battery now alarm) alarm at 12:08, and two (2) batt out limit (power loss) alarms at 12:19 that had occurred.No excessive or unusual power/battery related alarms noted in the history files.The pump was cut open for visual inspection.No damage or moisture damage was found on the electronic assembly (pcba 1 and pcba 2), motor, or force sensor and no obvious burned components or heat related damage.Moisture damage was found on the inside of the battery compartment.A test p-cap does lock into place inside the reservoir compartment properly.The following were noted during physical inspection: scratched case, serial number label stained, stained keypad overlay, pillowing keypad overlay, cracked battery compartment, and broken battery tube threads.Blank display, battery failed alarms, and device heating up are not confirmed.The pump was monitored for two (2) days and no blank display, battery failed alarms, unexpected additional power/battery alerts, or pump/battery heating up/hot to the touch noted.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: 13083280
• MDR Text Key: 291416752
• Report Number: 2032227-2021-234693
• 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: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• 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: HG40DUQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2019
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 225 KG