MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1712KL 640G V4.10 BK SF MG; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712KL

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Headache (1880); Hyperglycemia (1905); Polydipsia (2604)

Event Date 07/16/2022

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 pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion 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 insulin pump was under delivering the insulin.Customer was hospitalized due to high blood glucose.Blood glucose reading was 500 mg/dl.Customer stated that the reason the insulin pump was under delivering the insulin was the unexplained blood glucose and the bolus did not show any effect.Customer was using insulin pump within 48 hours of reported event.Customer reported symptoms such as unwell, headache and polydipsia.Customer was treated with intravenous insulin drip.Customer stated displacement test passed.No harm requiring medical intervention was reported.The device will be returned for the analysis.

Manufacturer Narrative

The test p-cap locks properly in place in the reservoir compartment noted.Pump received with pillowing keypad overlay during the visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.In further full review of the pump history on the event date of (b)(6) 2022, there is no unexpected alarms/suspends and found multiple bolus deliveries that the customer manually programmed and the daily total of bolus insulin delivered are 10.1u.Pump passed 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 0.08670 inches.Pump was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured (23.4 mv).The motor was tested outside of the device on the ngp stb3 and passed.In summary, pump passed all required testing.Unable to verify customer alleged for high bg.The force sensor is within specification and the motor functioning properly.Customer alleged for the pump under delivery 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-1712KL 640G V4.10 BK SF MG
• 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: 15119862
• MDR Text Key: 304552983
• Report Number: 2032227-2022-303775
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000367046
• UDI-Public: (01)000000763000367046
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712KL
• Device Catalogue Number: MMT-1712KL
• Device Lot Number: HG56VBG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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