MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712K

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

Patient Problem Death (1802)

Event Date 09/04/2020

Event Type  Death  

Manufacturer Narrative

The test p-cap and reservoir will not lock in place in the reservoir compartment due to missing retainer.The unit did not have a battery installed when received.Unit passed the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test and force sensor test.Unable to perform the displacement test, occlusion test and dat test due to missing retainer.The test p-cap and reservoir will not lock in place in the reservoir compartment due to missing retainer.Unit uploaded properly using carelink.Unit also had a missing reservoir tube o-ring, broken reservoir tube lip, minor scratched display window, scratched display window cover, scratched case and a pillowing keypad overlay.The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

It was reported via phone call that the customer passed away in an unknown location.The cause of death was unknown.The caller did not stated whether the customer had any illnesses that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.It is unknown if the customer was wearing the insulin pump at the time of death.It is unknown if the customer was using sensors.It was confirmed by medical personnel that there was no causal relationship between use of the insulin pump and the customer's passing.No further information was provided.The caller agreed to return the insulin pump for analysis.This report is only being created for the failure analysis results.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0958-2020.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: 640G INSULIN PUMP MMT-1712K
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 11294327
• MDR Text Key: 230751137
• Report Number: 2032227-2021-112131
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000643169999770
• UDI-Public: (01)000000643169999770
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712K
• Device Catalogue Number: MMT-1712K
• Device Lot Number: HG2TDE8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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
• Treatment: FRN-UNK-RSVR UNOMED SET; FRN-UNK-RSVR UNOMED SET
• Patient Outcome(s): Death