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 Problem Electrical /Electronic Property Problem (1198)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with a blank display due to moisture damage on the electronic assembly.Unable to perform the self test, sleep current measurement, active current measurement, and the displacement test or verify insulin pump error alarms due to blank display.Moisture damage was also found on the motor and force sensor during visual inspection.The pump was also received with stained keypad overlay, keypad overlay texture damage, end cap address label peeling and fading, case cracked behind the pump on the battery compartment, partially broken reservoir tube lip, missing retainer, scratched case, pillowing keypad overlay, and missing reservoir tube o-ring.A test p-cap and reservoir was installed and did not lock in place due to broken reservoir tube lip and missing retainer.The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.(b)(4).

Event Description

Information received by medtronic indicated that insulin pump had post-reset ram crc alarm.Customer reported that they were able to clear and rewind the insulin pump.No harm requiring medical intervention was reported.The insulin pump 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: 11065899
• MDR Text Key: 224248252
• Report Number: 2032227-2020-220701
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 0000006431696568
• UDI-Public: (01)0000006431696568
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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
• Device Lot Number: HG2ADN6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• 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