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 Problems Excess Flow or Over-Infusion (1311); Mechanical Problem (1384)

Patient Problems Hypoglycemia (1912); Dizziness (2194)

Event Date 11/08/2022

Event Type  Injury  

Event Description

Information received by medtronic indicated that the customer had pump error 37 and 43.Pump was unable to rewind.Delivered too much insulin to the customer and the customer experienced severe hypoglycemia.The customer was in the hospital and the pump was broken.Blood glucose value at the time of event was 1.9 mmol/l. the customer did experience sleepy, dizzy and not as responsive as symptoms of low blood glucose value.The customer treated low blood glucose with hospitalization and glucose tablet.It was unknown whether the auto mode feature was activated or not at the time of low blood glucose event.Troubleshooting was performed.No further patient complications were reported.The insulin pump will be returned for analysis.The customer will discontinue use of 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.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 insulin pump involved in this event is the ngp 640g insulin infusion 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.

Event Description

Missed/corrected description: pump does not have auto mode feature.Customer's mother reported that the customer was hospitalized due to a low blood glucose of 1.9 mmol/l on (b)(6) 2022 at 05:30.Per the caller the customer experienced pump errors 37 and 43 after he went swimming.She was able to clear the alarms, however, she could not complete the rewind process.She stated the insulin pump delivered too much insulin (1.7u within 10 minutes), and the customer had a severe hypoglycemic event as a result.The event occurred while the customer was sleeping at 03:30.Treatment was with glucose tablets, glucose gel, and food intake.The insulin pump was in use at the time of the event.The customer uses a competitor's sensor.

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 added, which was missed/incorrected in the initial report.The missed/corrected information has been provided in section b5 and h6 under health effect - impact code: 2199 with this report.

• 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: 15812176
• MDR Text Key: 307079650
• Report Number: 2032227-2022-361397
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000367039
• UDI-Public: (01)000000763000367039
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: HG4WDXS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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