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 Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Battery Problem (2885); Patient Device Interaction Problem (4001)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/01/2020

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.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 up button of insulin pump was stuck, replaced batteries more frequently every 5 to 6 days, insulin pump rejected new batteries, belt clip as superglue to insulin pump, motor was louder during rewind and cracks on side of insulin pump casing.No harm requiring medical intervention was reported.The device will be returned for analysis.

Manufacturer Narrative

Device passed the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test and force sensor test.The test p-cap does not lock in place properly and unable to perform the displacement test, displacement accuracy test and occlusion test due to missing retainer, missing reservoir tube o-ring and broken reservoir tube lip.The adapt tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within specific range.No replace battery alert or replace battery now alarm noted during testing or in the device trace download.Device received without the original belt clip.The test belt clip fits and lock properly and no damage on the belt clip rails noted.No unexpected motor noise during the rewind test.The motor was tested outside of the device and passed.All buttons functioning properly.No damage in the keypad assembly and the keypad connector on electrical board was locked properly during visual inspection.No sticky buttons noted.Device received with minor scratched lcd window, scratched case, scratched overlay, cracked case behind the device at the battery compartment and cracked battery tube threads.

Manufacturer Narrative

Narrative summary has been updated and provided with this report in section b5.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 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 up button of insulin pump was stuck, there was a dent next to the up button, they were replacing batteries more frequently every 5-6 days, insulin pump rejected new batteries, belt clip was super glued to insulin pump (it was having issues with its locking mechanism thus not holding the pump properly), motor was louder during rewind, and there were cracks on side of insulin pump casing.Crack was on the side of the battery compartment and there were also scratches on the side of battery compartment.There was also a large scratch on the top of the screen.The customer bumped into cabinet/doors.The retainer ring was not damaged.No harm requiring medical intervention was reported.The device will be returned for analysis.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0955-2020.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: 10763687
• MDR Text Key: 213918667
• Report Number: 2032227-2020-199360
• Device Sequence Number: 1
• Product Code: OZO
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2022

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 Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/20/2020; 11/24/2020; 10/14/2019
• Supplement Dates FDA Received: 11/23/2020; 11/26/2020; 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0955-2020
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 165 KG