MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711K

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 10/11/2021

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.The insulin pump involved in this event is the 640g insulin infusion insulin pump, which is not marketed in the insulin pumped states.However, the device is similar to the paradigm real-time insulin infusion insulin pump, which is marketed in the insulin pumped states.

Event Description

Information received by medtronic indicated that the insulin pump was not working and had lines on the screen.Customer was hospitalized due to high blood glucose and diabetic keto acidosis.Customer's blood glucose level was 35 mmol/l.The insulin pump will not be returned for analysis.

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 information related to product return status has been updated and provided in b5 section of this report.

Event Description

It was reported that the insulin pump will be returned for analysis.

Manufacturer Narrative

S.W version 4.11d, retainer ring = clear.Customer returned pump for an alleged missing segments/partial display and was hospitalized for high bgs and dka found on oct 11, 2021.Also, on (b)(4), svn#: (b)(6), customer returned pump for an alleged pump and meter communication anomaly found on (b)(6), 2021.Pump was received with a missing segments/partial display.Pump failed the self test due to missing segments/partial display.Pump passed the active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and data at 0.08655 inches.However, the pump had a high sleep current measurement.The pump was programmed with contour next test glucose meter.The pump connected successfully to the test meter and displayed ¿bg meter connection successful¿.No unexpected pump and bg meter communication errors or anomalies noted during testing.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.Power management graph was successfully generated.The loaded voltage (loaded vlith) and the unloaded voltage (unloaded vlith) display at the power graph management tool shows abnormal behavior.No alarms or alerts noted during the testing.However, low battery alert was recorded and found in the formatted history file on: (b)(6) 2021 19:39:00.000 on 09/27/2021 09:38:00.000 on (b)(6) 2021 12:23:00.000 insert battery alarm was recorded and found in the formatted history file on: (b)(6) 2021 19:41:17.000 on (b)(6) 2021 11:24:53.000 on (b)(6)2021 22:25:00.000 replace battery alert was recorded and found in the formatted history file on: (b)(6) 2021 21:54:00.000 and (b)(6) 2021 22:04:00.000 replace battery now alarm was recorded and found in the formatted history file on: (b)(6) 2021 22:25:00.000 and (b)(6) 2021 22:35:00.000 and power loss alarm was recorded and found in the formatted history file on: (b)(6) 2021 22:36:49.000 and (b)(6) 2021 22:37:01.000 pump was cut open to perform visual inspection and found missing segments/partial display.Corrosion was found on the vibrator assembly noted.No corrosion or moisture damage was found on the pcba1, pcba2, force sensor, motor assembly noted.The original pcba1 was installed in a test lcd board and original pcba2, case, internal battery and motor.Powered the pump on using the battery simulator and continued testing.No missing segments/partial display noted.However, the pump failed the sleep current measurement.The original pcba1/original lcd board was installed in a test pcba2, case, internal battery and motor.Powered the pump on using the battery simulator and continued testing.The pump failed the sleep current measurement.The original pcba2 was installed in a test pcba1, case, internal battery and motor.Powered the pump on using the battery simulator and continued testing.The pump passed the sleep current measurement.Missing segments/partial display, problem isolated on the lcd board.The pump had a high sleep current measurement, problem isolated on the pcba1.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 was noted during testing.The following were also noted during visual inspection: a stained keypad overlay, a pillowing keypad overlay, a cracked battery tube threads, a scratched case, a cracked case-corner of belt clip rails near the battery tube compartment and a serial number label fading.A cracked retainer was confirmed.Missing segments/partial display was confirmed.Missing segments/partial display, problem isolated on the lcd board.Unexpected battery power loss or replace battery alert/replace battery now alarm was confirmed.Unexpected battery power loss or replace battery alert/replace battery now alarm, problem isolated on the pcba1.Unable to verify customer alleged for high bgs and dka.The force sensor is within specification and the motor functioning properly.Pump and meter communication anomaly was not confirmed.During visual inspection, corrosion was found on the vibrator assembly noted.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: 640G INSULIN PUMP MMT-1711K
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 12646129
• MDR Text Key: 276827539
• Report Number: 2032227-2021-206305
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000192136
• UDI-Public: (01)000000763000192136
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Device Lot Number: HG30TW0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2018
• 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