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

Model Number MMT-1711B

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

Patient Problem Myocardial Infarction (1969)

Event Date 11/06/2021

Event Type  malfunction  

Event Description

It was reported via phone call that the customer passed away at home on (b)(6) 2021.The cause of death was heart attack.The customer¿s blood glucose was unknown at the time of death.The customer was wearing the insulin pump at the time of death.No further information was given.The insulin pump was returned for analysis.The case is reported on basis of failure analysis.

Manufacturer Narrative

(b)(4).On (b)(6) 2021 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 dat test at 0.0874 inches.The following were noted during visual inspection: minor scratched display window, scratched display window cover, scratched case, cracked battery tube threads, cracked case at corner of the belt clip rail, broken belt clip rail, faded end cap address label, pillowing keypad overlay, stained keypad overlay and a cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thus and carelink upload was successful.The insulin pump did not have a battery installed when received.The insulin pump passed the functional testing.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.

• Brand Name: 640G INSULIN PUMP MMT-1711B
• 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: 13365792
• MDR Text Key: 293358004
• Report Number: 2032227-2022-106501
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000643169739444
• UDI-Public: (01)000000643169739444
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711B
• Device Catalogue Number: MMT-1711B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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