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 Insufficient Flow or Under Infusion (2182)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Fatigue (1849); Headache (1880); Hyperglycemia (1905); Nausea (1970); Vomiting (2144)

Event Date 09/28/2021

Event Type  Injury  

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

The customer reported via phone call that they had visited the emergency room and admitted to the hospital overnight on (b)(6) 2021 due high blood glucose level.Customer's blood glucose value when admitted to hospital was 478 mg/dl.Customer reported feeling sick, unwell, flu, headache, tired such symptoms at the time of hospitalization.Customer also reported nausea, vomiting, abdominal pain, difficulty breathing such symptoms related to high blood glucose level.Customer treated high blood glucose with insulin pen or manual injection.Customer had been using the insulin pump system within 48 hours of reported high blood glucose event.Customer was assisted with troubleshooting.Customer alleged that the inulin pump was under delivering insulin.Customer performed high pressure test test and insulin pump passed the test.Customer stated cannula was bent.Reservoir and set had soda pop or champagne size air bubbles.The insulin pump will be returned for analysis.Frn-mmt 332a-rsvr, unomed set.

Manufacturer Narrative

The test p-cap locks properly in place in the reservoir compartment noted.Device received with cracked retainer, pillowing keypad overlay and cracked select button keypad overlay during visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.In further full review of the device history on the event date of (b)(6) 2021, there is no unexpected alarms/suspends and found multiple boluses delivered on 01:26:10 at 2 units, 03:39:10 at.75 units, 04:41:08 at 1.45 units and 07:37:26 at 10.875 units.Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test.Device was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured within specific range during testing (22.6 milivolts).The motor was tested outside of the device on the next generation insulin pump stb3 and passed.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.

Manufacturer Narrative

Updated analysis summary performed by (b)(6) on (b)(6) 2022.Updated analysis summary by (b)(6) on (b)(6) 2022 retainer ring = clear.Patient hospitalization for high blood glucose reported on (b)(6) 2021.Device was returned with an allegation of under delivery anomaly.The test p-cap locks properly in place in the reservoir compartment noted.Device received with cracked retainer, pillowing keypad overlay and cracked select button keypad overlay during visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.In further full review of the device history on the event date of (b)(6) 2021, there is no unexpected alarms/suspends and found multiple boluses delivered on 01:26:10 at 2u, 03:39:10 at.75u, 04:41:08 at 1.45u and 07:37:26 at 10.875u.Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08710 inches.Device was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured within specification range during testing (22.6 mv).The motor was tested outside of the device on the ngp stb3 and passed.Device tested ok.Unable to verify customer alleged for high blood glucose.Device was returned with an allegation not confirmed of under delivery anomaly.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.

Manufacturer Narrative

Updated analysis summary performed by lucas haug on (b)(6)2022.Updated analysis summary by alfred santos on (b)(6)2022 retainer ring = clear.Patient hospitalization for high blood glucose reported on (b)(6)2021.The insulin pump was returned with an allegation of under delivery anomaly.The test p-cap locks properly in place in the reservoir compartment noted.The insulin pump received with cracked retainer, pillowing keypad overlay and cracked select button keypad overlay during visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.In further full review of the insulin pump history on the event date of (b)(6)2021, there is no unexpected alarms/suspends and found multiple boluses delivered on 01:26:10 at 2u, 03:39:10 at.75u, 04:41:08 at 1.45u and 07:37:26 at 10.875u.The insulin pump passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08710 inches.The insulin pump was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured within specification range during testing (22.6 mv).The motor was tested outside of the device on the ngp stb3 and passed.Device tested ok.Unable to verify customer alleged for high blood glucose.The insulin pump was returned with an allegation not confirmed of under delivery anomaly.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.

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.

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.The initial report was submitted with missing information.The information had been updated and provided with this report in section b5.

Event Description

Customer reported presence of kinked tubing.

• 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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 12553049
• MDR Text Key: 273985743
• Report Number: 2032227-2021-199854
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169656840
• UDI-Public: (01)000000643169656840
• 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,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG232SD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• 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: 70 YR
• Patient Sex: Male