MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KL

Device Problem Obstruction of Flow (2423)

Patient Problems Fatigue (1849); Headache (1880); Hyperglycemia (1905); Confusion/ Disorientation (2553); Polydipsia (2604)

Event Date 12/05/2021

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.

Event Description

The customer reported via phone call that they were taken to hospital by ambulance for high blood glucose level on (b)(6), 2021.Customer's blood glucose level was 600 mg/dl at the time of hospitalization.Customer was treated with intravenous insulin drip at the hospital.Customer reported confusion, sickness, flu like, headache, tired, weakness and increased thirst as symptoms of high blood glucose level.Customer did not feel okay to troubleshoot.Customer reported insulin pump had insulin flow blocked alarms prior going to hospital.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.The insulin pump will be returned for analysis.

Manufacturer Narrative

Retainer ring = black on (b)(6) 2021 the customer alleged was hospitalized for high blood glucoses and insulin flow blocked alarm.The test p-cap locks properly in place in the reservoir compartment noted.Device received with pillowing keypad overlay, cracked case near the corner of belt clip rails, cracked battery tube threads and cracked case above the arrow and battery cap icon during the visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.In further full review in the insulin pump history found eleven insulin flow blocked alarms on the event date of dec 05, 2021 in the insulin pump history at 02:25:00 until 13:32:49 all during basal deliveries.Device 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 delivery accuracy test at 0.08720 inches.No unexpected insulin flow blocked alarm during testing.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.The motor was tested outside of the device on the ngp stb3 and passed.In summary, insulin pump passed all required testing.Unable to verify customer alleged for high blood glucoses.The force sensor is within specification and the motor functioning properly.Customer alleged for insulin flow blocked alarm was not confirmed.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.

Manufacturer Narrative

Updated analysis summary by (b)(6) on (b)(6) 2022.Retainer ring = black.On (b)(6) 2021, the customer alleged was hospitalized for high bgs, insulin flow blocked alarm and cosmetic damage insulin pump.The test p-cap locks properly in place in the reservoir compartment noted.Device received with pillowing keypad overlay, cracked case near the corner of belt clip rails, cracked battery tube threads and cracked case above the arrow and battery cap icon during the visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.In further full review in the pump history found eleven insulin flow blocked alarms on the event date of (b)(6) 2021, in the pump history at 02:25:00 until 13:32:49 all during basal deliveries.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 delivery accuracy test at 0.08720 inches.No unexpected insulin flow blocked alarm during testing.Device 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 (22.9 mv).The motor was tested outside of the device on the ngp stb3 and passed.In summary, insulin pump passed all required testing.Unable to verify customer alleged for high bgs.The force sensor is within specification and the motor functioning properly.Customer alleged for insulin flow blocked alarm was not confirmed.Cosmetic damage confirmed on the keypad overlay, case near the corner of belt clip rails, battery tube threads and case above the arrow and battery cap icon.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.

• Brand Name: 630G INSULIN PUMP MMT-1715KL 630G
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 13015571
• MDR Text Key: 282699788
• Report Number: 2032227-2021-230991
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)231207
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/07/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4XG0X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 88 KG