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 Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2022

Event Type  Death  

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

It was reported via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2021 due to colon ruptured blood glucose.The cause of death was unknown.The caller stated that the cause of death is still unknown.The caller stated that the customer had diabetes, colon stage 4 renal failure ,congestive heart failure that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The customer was not wearing the insulin pump at the time of death.The caller stated that the insulin pump was last worn by the customer on (b)(6) 2021.The caller stated that the customer was not wearing the insulin pump at the time of deceased event as the hospital removed it.It is unknown if the caller will return the insulin pump for analysis.

Manufacturer Narrative

Retainer ring = black.On (b)(6) 2022 the customer passed.The insulin pump 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 delivery accuracy test at 0.0873 inches.The following were noted during visual inspection: minor scratched display window, scratched case and pillowing keypad overlay.History download was successful using thus and carelink upload was successful.The pump received with a depleted duracell alkaline battery installed.Please see below for the customer's daily total of all insulin delivered surrounding the event date (b)(6) 2022 listed on smartsolve and the days prior to the event date.(b)(6) 2021 dailytotalofallinsulindelivered = 36.075 (b)(6) 2021 dailytotalofallinsulindelivered = 36.575 (b)(6) 2021 dailytotalofallinsulindelivered = 20.95 (b)(6) 2021 dailytotalofallinsulindelivered = 1.5 (b)(6) 2021 dailytotalofallinsulindelivered = 0 (b)(6) 2021 dailytotalofallinsulindelivered = 18.025 (b)(6) 2022 dailytotalofallinsulindelivered = 2.175.The insulin pump passed the functional testing.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-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
• 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: 13275583
• MDR Text Key: 283928274
• Report Number: 2032227-2022-103845
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316631
• UDI-Public: (01)000000763000316631
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• 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: HG444QH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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): Death
• Patient Age: 66 YR
• Patient Sex: Male