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 Computer Software Problem (1112); Electrical /Electronic Property Problem (1198); Date/Time-Related Software Problem (2582); Communication or Transmission Problem (2896); Loss of Data (2903)

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

Event Date 09/28/2021

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 68, pump error 53, pump error 23, pump error 3, pump error 28 occurred.There was no adverse impact or consequence reported as a result of this event.

Manufacturer Narrative

Retainer = missing.Customer returned the insulin pump for alleged multiple pump error 3, 23, 28, 53, and 68 alarms found on 9/28/2021.Device was received with partially broken reservoir tube lip, missing retainer and missing reservoir tube o-ring.Device passed the rewind test, prime/seating test, basic occlusion test, force sensor test, self test, sleep current measurement, and active current measurement however, unable to perform the displacement test, occlusion test, and delivery accuracy test due to broken reservoir tube lip and missing retainer.No pump error 3, pump error 28, pump error 53 alarms or unexpected pump error 23 and pump error 68 alarms noted during testing.Successfully downloaded the trace and history files using thus.A reviews of the history files reveals that on (b)(6) 2021 there were three (3) pump error 28 alarms at 20:12, 20:14, 20:55, three (3) pump error 3 (linenumber 2723 file number 124) alarms at 20:12, 20:15, and 20:55, and four (4) pump error 53 (linenumber 3200 file number 459) alarms at 20:21, 20:14, 20:15, and 20:55 and then on (b)(6) 2021 there were two (2) pump error 28 alarms at 09:22 and 10:31, two (2) pump error 3 (linenumber 2723 file number 124) alarms at 09:23 and 10:31, and four (4) pump error 53 (linenumber 3200 file number 459) alarms at 2x 09:23 and 2x 10:31that occurred due to software errors.Further review of the history file shows two (2) pump error 23 alarms at 20:23 and 20:57 and three (3) pump error 68 alarms at 12:12, 12:15.And 20:55 alarms that occurred.No excessive pump error 23 or pump error 68 alarms found in the history files.Device was cut open to perform a visual inspection.No damage or moisture damage on the electronic assembly (pcba 1 and pcba 2), motor, or force sensor noted.A test p-cap was installed and did not lock in place due to broken reservoir tube lip and missing retainer.The following were noted during physical inspection: partially broken reservoir tube lip, missing retainer, scratched case, pillowing keypad overlay, cracked select button keypad overlay, stained keypad overlay, missing display window cover, missing serial number label, missing end cap address label, missing reservoir tube o-ring, battery compartment cracked at the corner of the belt clip rails, and cracked battery tube threads.Pump error 3, pump error 28, and pump error 53 alarms are confirmed due to software errors.Pump error 23 and pump error 68 alarms are not confirmed.No unexpected pump error 23 or pump error 68 alarms during testing or excessive alarms in the history files.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: 13718242
• MDR Text Key: 289528511
• Report Number: 2032227-2022-124637
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169782396
• UDI-Public: (01)000000643169782396
• 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: 04/14/2022

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: HG28Q4N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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