MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KL

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

The customer reported via phone call that they experienced low blood glucose level.The customer¿s blood glucose level was 191 mg/dl at the time of the incident.Customer was treated with food and glucose tablets.Customer had alleged that the insulin pump was over delivering.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.Insulin pump was not working correctly and kept delivering too much insulin.Insulin pump continue to deliver bolus and made the customer went down continuously.Troubleshooting was performed successfully however, the customer will discontinue the use of device.

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.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

Retainer ring = black.Customer returned pump for an alleged low bgs/over delivery on 02/15/2022.Test p-cap and reservoir locked properly into reservoir compartment during testing.The pump passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test and self test.The pump was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts and were properly recorded in the daily history.No delivery anomaly, bolus anomaly or basal anomaly noted during testing.Successfully downloaded history files and traces using thus software.The pump uploaded to carelink pro without any errors.However, history file shows normal bolus delivery on 02/15/2022 06:57:11.000 normalbolusprogrammed 02/15/2022 06:58:32.000 normalbolusdelivered.02/15/2022 13:49:05.000 boluswizardestimate.02/15/2022 13:49:09.000 normalbolusprogrammed.02/15/2022 13:51:30.000 normalbolusdelivered.02/15/2022 17:11:06.000 boluswizardestimate.02/15/2022 17:11:07.000 normalbolusprogrammed.02/15/2022 17:12:08.000 normalbolusdelivered.02/15/2022 17:53:57.000 boluswizardestimate.02/15/2022 17:53:59.000 normalbolusprogrammed.02/15/2022 17:55:40.000 normalbolusdelivered.In summary, customer alleged low bgs/over delivery not confirmed.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

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.Information has been corrected which was not correct in the initial report.The information has been provided in section h6 with this report.

• Brand Name: 630G INSULIN PUMP MMT-1715KL 630G
• 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: 13566974
• MDR Text Key: 296401998
• Report Number: 2032227-2022-116015
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)240827
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2022

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 Expiration Date: 08/27/2024
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5MQM9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 06/21/2022; 09/24/2022
• Supplement Dates FDA Received: 06/30/2022; 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 73 KG