MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711K

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

Patient Problem Cancer (3262)

Event Date 08/20/2019

Event Type  Death  

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Correction/removal number: z-0958-2020.(b)(4).S/w 2.6d.The unit did not have a battery installed when received.Unit passed the 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 0.08720 inches.Pump error 63 (variable 3) alarmed during self test due to broken trace at u1 pin 6 (sda) on keypad assembly.Toggled on/off and increased/decreased volume with the audio feature functioning properly.No audio/vibrate/absence of alarm anomalies noted during testing.Unit uploaded properly using carelink.Unit had minor scratched display window, missing display window cover, scratched case, cracked battery tube threads, cracked case at the corner of the belt clip rail, stained/peeling serial number label, pillowing keypad overlay, cracked keypad overlay at the select button and a cracked retainer.Data analysis: (the date of death was not specified in the customer notes.) the formatted history file lists data from (b)(6) 2016 to (b)(6) 2019.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.

Event Description

It was reported via phone call that the customer passed away.The cause of death was cancer.The caller stated that they did not wanted to provide information about customer's death.The customer¿s blood glucose level was unknown at the time of death.It was unknown if the customer was wearing the insulin pump at the time of death.It was unknown if the customer was using sensors at the time of death.The insulin pump was returned for analysis.Frn-unk-rsvr, unomed inf set.

• Brand Name: 640G INSULIN PUMP MMT-1711K
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 15039794
• MDR Text Key: 296049025
• Report Number: 2032227-2022-289371
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169554931
• UDI-Public: (01)00643169554931
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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-1711K
• Device Catalogue Number: MMT-1711K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• 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-0958-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death