MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.(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

Medtronic received information that pump error 130, damage (physical or cosmetic) occurred.There was no adverse impact or consequence reported as a result of this event.

Manufacturer Narrative

Retainer ring=black.Customer complained on (b)(6) 2021 pump alarmed pump error 130 and is experiencing high bg.Complained the keypad is cracked.Device passed active current measurement, sleep current measurement test, selftest, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.Device successfully downloaded to thus.No pump error 130 alarms noted during test.However, verified in the pump history download the pump alarmed pump error 130 on (b)(6) 2021 17:12:23.000.Motor was tested outside of the device and passed.The motor had a intermittent failure not detected during test.The following were noted during visual inspection: scratched case, pillowing keypad overlay and cracked keypad overlay.The p-cap/reservoir does lock properly.Device passed functional testing.No pump error 130 alarms noted during test.However, confirmed the pump alarmed pump error 130 on (b)(6) 2021 17:12:23.000.Confirmed cracked keypad overlay.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: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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: 13799822
• MDR Text Key: 287705614
• Report Number: 2032227-2022-146150
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000315702
• UDI-Public: (01)000000763000315702
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG489UB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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