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 Device Alarm System (1012); Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

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.

Event Description

Information received by medtronic indicated that the insulin pump buttons were harder to push.Customer stated that insulin pump was alarming and beeping was not as loud.Insulin pump declined rewinding.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.

Manufacturer Narrative

S/w version 4.11c retainer ring = clear case type =ngp customer returned pump for alleged motor anomaly and audio anomaly and keypad unresponsive on 23 december 2020.Unit was received with battery cap and found no anomalies on battery cap.Unit passed the self-test, displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test and occlusion test.Unit was responsive during testing.Received pump with audio turned off in settings.Toggled on/off and increased/decreased volume with the audio feature functioning properly.No audio anomaly and keypad unresponsive and motor anomaly noted during testing, and p-cap locks properly into the reservoir compartment, however, it was noted as damaged due to cracked retainer.Unit successfully downloaded to thus for history files and traces.Unit was downloaded using carelink.Stuck key alarm ((b)(6) 2020 14:46) in history files and traces.Pump was cut to perform visual inspection found moisture damage on the force sensor.Motor was tested outside of unit and it passed.The following were noted during visual inspection: corroded battery tube, scratched case, cracked keypad overlay, stained keypad overlay, pillowing keypad overlay, stained serial label, cracked retainer.Keypad unresponsive is not confirmed.The keypad overlay was responsive during testing.Motor anomaly is not confirmed.Audio anomaly is not confirmed.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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 11099477
• MDR Text Key: 225571631
• Report Number: 2032227-2020-222546
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000190439
• UDI-Public: (01)000000763000190439(17)220605
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2022
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG3GS70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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: 44 YR
• Patient Sex: Male