MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

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

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer had high blood glucose.Blood glucose value was 17.5 mmol/l.The customer reported that they treated high blood glucose by using bolus using insulin pump.The auto mode feature was inactive at the time of high blood glucose event.The troubleshooting was performed.The customer was using the insulin pump system within 48 hours of reported high blood glucose event.The customer did experience symptom such as tired and sick due to high blood glucose level.The device will not be returned for analysis.

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Customer complained on (b)(6) 2021 is experiencing high bg.Unit passed active current measurement, sleep current measurement test, selftest, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.Unit successfully downloaded to thus.The electronic assemblies and motor assemblies were inspected and no anomalies noted.The following were noted during visual inspection: corroded battery tube, scratched case, pillowing keypad overlay and cracked retainer.The p-cap/reservoir does lock properly.Pump passed functional testing.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 14460456
• MDR Text Key: 293370076
• Report Number: 2032227-2022-193074
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169782396
• UDI-Public: (01)000000643169782396
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• 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