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 Problems Hypoglycemia (1912); Coma (2417); Loss of consciousness (2418)

Event Date 08/21/2017

Event Type  Injury  

Event Description

Spouse of customer reported that his wife was hospitalized 3 weeks prior and was currently in the hospital due to diabetic coma and severe brain injury.He also inquired about a recall on infusion sets.Spouse reported that the customer had been experiencing low blood glucose levels before she was found unconscious 16 hours later.She also had multiple suspensions and resumes of basal in her pump history.A field rep later confirmed that the customer was hospitalized on (b)(6) 2017 and passed away on (b)(6) 2017.

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 unit did not have a battery installed when received.Unit 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 0.08730 inches.Unit uploaded properly using carelink.The formatted history file lists multiple suspend activity.The latest suspend activity was on (b)(6) 2017 for low predicted suspend, suspend predict threshold, threshold suspend input, tsuspendmxst, suspended by alarm, and low threshold suspend.The long trace history file lists some data on (b)(6) 2017 for button presses activity.The suspended and resume options functions properly when using the suspend delivery feature.No anomaly noted when using the suspend delivery feature.Unit had scratched case, pillowing keypad overlay and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: from 10/04/2017 to 10/10/2017 daily total of all insulin delivered = 0.On (b)(6) 2020: the case bottom was milled off to perform a visual inspection.During the visual inspection, no moisture damage or loose components noted on the electronic assembly.No damage noted on the motor assembly.

• 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: 14975048
• MDR Text Key: 295602672
• Report Number: 2032227-2022-279935
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169739468
• UDI-Public: (01)00643169739468
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• 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: 03/27/2020
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization