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 Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Fall (1848); Hypoglycemia (1912); Unspecified Heart Problem (4454); Renal Impairment (4499)

Event Date 01/08/2022

Event Type  Death  

Event Description

It was reported via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) , 2021 because they feel that they were injured and the sugar drooped to 30 mg/dl.The customer think that cause of death was cardiac arrest and they hasn't got death certificate.Customer has fallen and found he had injury to cervial spin which caused is diaphragm stopped working.The caller stated that the customer had heart circulation issue and kidney issue that may have led to the customer's passing.The customer¿s blood glucose was 30 mg/dl at the time of death.The customer was wearing the insulin pump at the time of death.The customer was using sensors.It was unknown whether the insulin pump was on auto mode or not during the event.The caller it is unknown , if the caller will return the insulin pump for analysis.

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

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.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.The information related to event has been updated and provided in b5 section of this report.

Event Description

Customer's daughter reported that prior to passing, the customer used mmt-1715kl (sn (b)(6)).The cause of death was is unknown.Caller did not get the death certificate yet.Caller thought it might be cardiac arrest.Customer was admitted on (b)(6) 2021 after he fell and was injured due to low blood glucose of 30mg/dl.Emergency medical technicians took him to the hospital.They found he had injury to the cervical spine, which caused the diaphragm to stop working.Customer never came out of the hospital and passed on (b)(6) 2022 in the hospital.Other health issues customer had were heart issues, circulation issues, and kidney issues.Per complaint text, customer continued to use (b)(6) that was part of the recall until he went to the hospital (even though he was told to discontinue the pump before).In the hospital, the educator set him up on the replacement pump (b)(6).Customer was also hard of hearing.Pump was worn at passing.Sensor was used.There was no auto mode feature on the pump.

• 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: 13408658
• MDR Text Key: 284788744
• Report Number: 2032227-2022-107416
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)241025
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5UGCY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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-UNK-RSVR, UNOMED SET.
• Patient Outcome(s): Hospitalization; Death
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 215 KG