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); Obstruction of Flow (2423)

Patient Problem Hypoglycemia (1912)

Event Date 02/20/2023

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.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 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 reported insulin flow block alarm and reported pump over delivery.Troubleshooting was performed and found that the insulin exited during the 5.0u fill cannula.It was stated that after the insulin flow block, suddenly the blood glucose started to shoot down.No harm requiring medical intervention was reported.The customer will discontinue the use of the device and revert to the backup plan as per health care professional instructions.The pump will be returned for analysis.

Manufacturer Narrative

Test p-cap and reservoir locked properly into reservoir compartment during testing.No damage to retainer ring during visual inspection noted.The pump passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test and self-test.The pump was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts and were properly recorded in the daily history.No data anomaly noted during carelink pro download.No unexpected occlusions or delivery anomaly, bolus anomaly or basal anomaly noted during testing.Successfully downloaded history files and traces using thus.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the pcba1, pcba2, force sensor, motor and vibrator assembly noted.The following were noted during visual inspection, fading serial number label.In summary, customer alleged no delivery/occlusion alarm during therapy 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: 16529961
• MDR Text Key: 311153417
• Report Number: 2032227-2023-169751
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• 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: HG5ZWDR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/19/2023
• 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