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

Model Number MMT-1715KR

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 07/01/2022

Event Type  Injury  

Event Description

The customer reported via phone call that they experienced low blood glucose level.Customer¿s blood glucose level was 35 mg/dl at the time of incident and current blood glucose was 220mg/dl.Customer was treated with food low blood glucose level and they experienced shaking and sweating.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.Customer alleges insulin pump was over delivering insulin because blood glucose was still dropping.Customer declined troubleshooting for low blood glucose level.No further patient complication were reported.The customer will continue to use the 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.

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.For second follow up report, type of reportable event h1 was selected as malfunction which was wrong.The correct type of reportable event h1 for second follow up report is serious injury.

Manufacturer Narrative

Additional information has been added which was not included with the initial report.The information has been provided in section h7 and h9 with this report.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 = clear.Customer returned pump for an alleged possible over delivery and low bgs found on (b)(6), 2022.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 (b)(4).Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.Please see below for the date range listed in the formatted history file.The formatted history file lists data from (b)(6) 2009 00:00:58.000, (b)(6) 2019 13:07:59.000 to (b)(6) 2022 22:06:28.000 and (b)(6) 2022 01:16:50.000 to (b)(6) 2022 07:53:57.000 there was no data available to verify unexpected alarms/suspends and bolus delivery for the event date of july 01, 2022.Device was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts (at quick bolus speed) and were properly recorded in the daily history.No bolus delivery anomaly or history anomaly noted.No under delivery anomaly or over delivery anomaly noted during testing.Device was cut open to perform visual inspection and found slight corrosion on the pcba 1 and pcba 2.No corrosion or moisture damage found on the force sensor, motor or vibrator¿assembly noted.Force sensor zero offset within specification (22.9 mv).The motor was tested outside of the device on the ngp stb3 and passed.The test p-cap and reservoir locked properly into reservoir compartment.However, a cracked retainer and a cracked reservoir tube lip were noted during testing.The following were also noted during visual inspection: a missing display window/cover, a keypad overlay peeling, a cracked battery tube threads, a scratched case and a cracked case behind the pump near the battery tube compartment.A cracked retainer and a cracked reservoir tube lip were confirmed.Device passed all the required testing.Unable to verify customer alleged for low bgs.The force sensor is within specification and the motor functioning properly.Customer alleged for possible over delivery was not confirmed.However, during visual inspection, found slight corrosion on the pcba 1 and pcba 2.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-1715KR 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: 15101132
• MDR Text Key: 296567939
• Report Number: 2032227-2022-300830
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000173036
• UDI-Public: (01)000000763000173036
• 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
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG3578J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 08/01/2022; 09/09/2022; 09/09/2022
• Supplement Dates FDA Received: 08/04/2022; 09/09/2022; 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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
• Treatment: FRN-MMT-332-RSVR, UNOMED SET.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 110 KG