MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1711KL 640G V4.10 BK SF MM; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711KL

Device Problem Failure of Device to Self-Test (2937)

Patient Problem Hypoglycemia (1912)

Event Date 12/05/2022

Event Type  malfunction  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.The insulin pump involved in this event is the ngp 640g insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin pump, which is marketed in the united states.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.

Event Description

Information received by medtronic indicated that the customer performed displacement test and insulin pump did not pass the test.Customer was hospitalized due to hypoglycemia.Customer's blood glucose level was 6.12 mmol/l at the time of incident.The current blood glucose value was 3.3 mmol/l.Customer was treated with glucose tablet.Troubleshooting was performed.Customer was advised that the pump will be replaced.No harm requiring medical intervention was reported.The device will not be returned for product 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 that provided with the initial report was incorrect.The correct information has been included with this report in b3 section.

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.Retainer ring = black.Case type = ngp.Customer returned pump for an alleged sensor glucose/blood glucose (sg/bg) anomaly, visit to emergency room, ems dispatched and was hospitalized for low bgs found on (b)(6) 2022.The 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 dat at 0.08750 inches.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.Please see below for pump errors/alarms noted 1 week prior to the event date 05-dec-2022 in the formatted history file.Lost sensor 1 alert (780) was recorded and found in the formatted history file on: 12/04/2022 01:08:00.000, 12/04/2022 01:18:00.000.Sg calibration error (776) was recorded and found in the formatted history file on: 12/04/2022 12:37:42.000.Sensor error alert (801) was recorded and found in the formatted history file on: 12/04/2022 11:07:45.000, 12/04/2022 11:09:14.000, 12/04/2022 11:37:54.000, 12/04/2022 12:42:40.000.The pump was programmed with contour next test glucose meter.The pump connected successfully to the test meter and displayed ¿bg meter connection successful¿.The pump communicated properly and recorded the 122 mg/dl test value properly from glucose meter.The pump sensor feature is working properly.No unexpected bg meter communication errors or anomalies noted during testing.The pump was programmed with a test guardian link (3) transmitter and a 240 mg/dl glucose sensor simulator.The pump connected successfully to the transmitter and displayed ¿transmitter connection successful¿.The pump communicated properly with glucose sensor simulator and displayed the calibrate your sensor alarm properly after completion of the warm up.The pump calibrated and displayed the programmed value of 240 mg/dl properly on the display graph.No unexpected sensor errors or anomalies were noted during testing.No sensor glucose/blood glucose (sg/bg) anomaly noted.There were no unexpected pump errors/alarms/alert noted.The pump was received without a battery cap installed.The pump was received without a battery installed.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: a scratched case, a cracked case behind the pump near the battery tube compartment and a cracked case-corner of belt clip rails near the battery tube compartment.The pump passed all the required testing.Unable to verify customer alleged for low bgs.Sensor glucose/blood glucose (sg/bg) anomaly was not confirmed.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-1711KL 640G V4.10 BK SF MM
• 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: 16032503
• MDR Text Key: 308239415
• Report Number: 2032227-2022-384970
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: LO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711KL
• Device Catalogue Number: MMT-1711KL
• Device Lot Number: HG5ZWDU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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