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 Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Anxiety (2328); Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Date 10/28/2022

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 customer visited emergency room services due to hypoglycemia with a blood glucose value of 50 mg/dl at the time of the event.Another blood glucose value was 120 mg/dl.The customer experienced symptoms such as shaking, anxiety, and mental confusion.The low blood glucose was treated with food and glucose tablets.The customer is using the insulin pump system within 48 hours of the reported low blood glucose event.It was unknown whether the auto mode feature was active at the time of the event.Troubleshooting was performed and found that the pump over delivered the insulin because of hypoglycemia.No further patient complications were reported.The customer will discontinue the use of the insulin pump and will 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.Retainer ring = black.Case type = ngp customer returned device for an alleged possible over delivery and low bgs found on october 28, 2022.Customer's note stated the customer was not hospitalized.The 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 dat at 0.08725 inches.Successfully downloaded history files and traces using thus.Successfully uploaded device to carelink.In further full review of the device history/traces on the event date of october 28, 2022, there is no unexpected alarms/suspends and found bolus delivery of dailytotalofbolusinsulindelivered = 34.775 u.The 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 no evidence of physical or moisture damage on the electrical board force sensor, motor and vibrator assembly noted.Force sensor zero offset within specification (23.0mv).The motor was tested outside of the device on the ngp stb3 and passed.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: a scratched case.The pump 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.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.Initial report was submitted with missing information.The corrected information has been updated and provided in section b5.

Event Description

The customer reported via phone call that they were experienced low blood glucose level.Insulin pump was returned.Frn-unk-rsvr, unomed set.

• 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: 15850789
• MDR Text Key: 307004035
• Report Number: 2032227-2022-364629
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317195
• UDI-Public: (01)000000763000317195
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• 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: HG62MUF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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