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 Break (1069)

Patient Problem Cancer (3262)

Event Date 03/06/2019

Event Type  Death  

Event Description

It was reported via phone call that the customer passed away at home.The cause of death was cancer.The caller was unsure if the customer was wearing the insulin pump at the time of death.The caller returned the insulin pump for analysis.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.(b(4).S/w 2.9d.The device did not have a battery installed when received.Device 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 0.08770 inches.Device had cracked case at battery tube side, cracked battery tube threads, minor scratched display window, scratched case, pillowing keypad overlay, stained keypad overlay and a cracked retainer.Data analysis: (date of customer passing: unable to provide info.) the formatted history file lists data from (b)(6) 2018 to (b)(6) 2019.

• 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: 15038854
• MDR Text Key: 296044775
• Report Number: 2032227-2022-288577
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169662568
• UDI-Public: (01)00643169662568
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 07/17/2022

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: Other
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2016
• 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