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

Model Number MMT-1715K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 10/05/2020

Event Type  Death  

Event Description

It was reported via phone call that the customer passed away in hospital.The date on which customer was hospitalized was unknown but it was due to she fell and had a head injury.The cause of death was head injury.The customer's spouse stated that the customer's sugar have not led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The customer was wearing the insulin pump at the time of death.The customer was not using sensors.The auto mode on the insulin pump active and automatically adjusting insulin delivery during the event was unknown.The caller agreed to return the insulin pump for analysis.

Manufacturer Narrative

"this report is part of a retrospective review and remediation efforts in response to a warning letter.Z-0955-2020.(b)(4).S/w 4.11c.The unit did not have a battery installed when received.Unit passed the functional test, 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 the dat test at 0.08730 inches.Unit uploaded properly using carelink.Unit had scratched case, pillowing keypad overlay and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: 09/27/2020, daily total of all insulin delivered = 24.1.09/28/2020 daily total of all insulin delivered = 24.6.09/29/2020 daily total of all insulin delivered = 21.6.09/30/2020 daily total of all insulin delivered = 21.6.10/01/2020 daily total of allinsulin delivered = 21.6.10/02/2020 daily total of all insulin delivered = 21.6.10/03/2020 daily total of alli nsulin delivered = 14.45.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-1715K 630G BLACK MG
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 15039175
• MDR Text Key: 296045238
• Report Number: 2032227-2022-289438
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000190439
• UDI-Public: (01)000000763000190439
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG3UFT2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0955-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR