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); Nausea (1970); Diabetic Ketoacidosis (2364); Polydipsia (2604)

Event Date 09/21/2022

Event Type  Injury  

Event Description

Information received by medtronic stated that the customer was hospitalized on (b)(6) 2022 for a hyperglycemia along with diabetes ketoacidosis.Customer blood glucose level was 28.6 mmol/l.Customer experienced symptoms like nausea and thirst due to high blood glucose.Customer was treated with intravenous insulin and injections.Customer was used insulin pump system within 48 hours of reported event.No harm was required during medical intervention.The devise was returned for analysis.

Manufacturer Narrative

(b)(4).Retainer ring is clear.On (b)(6) 2022, the customer alleged was hospitalized for high blood glucose and diabetes ketoacidosis.The test p-cap locks properly in place in the reservoir compartment noted.Insulin pump received with cracked retainer, pillowing keypad overlay, serial number label fading, cracked battery tube threads and cracked case near the corner of belt clip rails during the visual inspection.Thus and care link software was utilized and downloaded trace/history files properly.Insulin pump passed 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 dat at 0.08720 inches.Insulin pump was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured within spec range during testing (22.4 millivolt).The motor was tested outside of the device on the next generation insulin pump stb3 and passed.In summary, insulin pump passed all required testing.Unable to verify customer alleged for high blood glucose and diabetes ketoacidosis.The force sensor is within specification and the motor functioning properly.The insulin pump involved in this event is the 640g insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin pump, which is marketed in the united states.

• 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: 15892273
• MDR Text Key: 304591475
• Report Number: 2032227-2022-368499
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000068998
• UDI-Public: (01)000000763000068998
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2018
• 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