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 Hyperglycemia (1905); Hypoglycemia (1912); Diabetic Ketoacidosis (2364); Coma (2417); Loss of consciousness (2418)

Event Date 11/19/2018

Event Type  Death  

Event Description

It was reported that the customer passed away in hospice care.The customer was hospitalized on (b)(6) 2018.The cause of death was lung cancer.The caller did not state whether the customer had any other illnesses that may have led to the customer's passing.The customer¿s blood glucose was 216 mg/dl at the time of admission, and 83 mg/dl at the time of passing.The customer was wearing the insulin pump at the time of death.The caller mentioned death following loss of consciousness and the customer being found on the floor with diabetic ketoacidosis, a coma or other complications.The caller also stated the customer had been given glucagon due to a low.The customer was using sensors.The caller did not state whether they would return the insulin pump for analysis.Updated summary: pump upload revealed a lot of suspend before low alerts that the customer did not respond to.Correction: the blood glucose of 83mg/dl was in the last moments prior to passing but not the last blood glucose.

Manufacturer Narrative

"this report is part of a retrospective review and remediation efforts in response to a warning letter.(b)(4).S/w 4.10d.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 had minor scratched display window, scratched case, pillowing keypad overlay and cracked retainer.Data analysis (date of death: (b)(6) 2018).On (b)(6) 2018 dailytotalofallinsulindelivered = 15.45.On (b)(6) 2018 dailytotalofallinsulindelivered = 15.3.On (b)(6) 2018 dailytotalofallinsulindelivered = 12.275.On (b)(6) 2018 dailytotalofallinsulindelivered = 12.7.On (b)(6) 2018 dailytotalofallinsulindelivered = 14.425.On (b)(6) 2018 dailytotalofallinsulindelivered = 12.275.On (b)(6) 2018 dailytotalofallinsulindelivered = 8.

• 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: 15049353
• MDR Text Key: 296121545
• Report Number: 2032227-2022-291779
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00763000068998
• UDI-Public: (01)00763000068998
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• 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: 07/19/2022
• 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
• Device Lot Number: HG27GGZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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; Death