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 Problems Insufficient Flow or Under Infusion (2182); Power Problem (3010)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 07/28/2021

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 experiencing high blood glucose.Blood glucose level at the time of the incident was 400 mg/dl which was treated with manual injections.Customer was alleging insulin pump for under delivery.Customer stated that insulin pump did not recognized new battery.Insulin pump passed displacement test.Customer was experiencing high blood glucose symptom like no energy.Customer was using insulin pump within 48 hours of high blood glucose incident.The insulin pump will be returned for analysis.

Manufacturer Narrative

Retainer ring = black customer complained about having possible under delivery anomaly/failed battery test alarm on the pump on (b)(6) 2021.The thus/carelink download was successful.Daily total screen showed 13.7u was delivered on (b)(6) 2021.The power management graph confirmed the unloaded voltage and loaded voltage was within specification range.No unexpected pump error 25, low battery alert, battery power loss alarm, replace battery alert, replace battery now alarm or failed battery test alarm noted in the pump trace download.Device passed functional testing including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test.The dat test at 0.08730 inches.No unexpected possible under delivery anomaly or failed battery test alarm noted during testing.No cosmetic damage noted and the p-cap locks properly into place.Device was cut opened, inspected and tested.No physical damage or moisture damage found on the electronic assembly, motor assembly, force sensor and battery tube.Motor passed the motor test outside of the device.In conclusion, possible under delivery anomaly an failed battery test 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.

• 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: 12286083
• MDR Text Key: 265352248
• Report Number: 2032227-2021-177317
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)230925
• 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
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4Q04W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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
• Treatment: FRN-MMT-332A-RSVR, UNOMED INF SET.; FRN-MMT-332A-RSVR, UNOMED INF SET.
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 58 KG