MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

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

Patient Problems Headache (1880); Hyperglycemia (1905); Visual Impairment (2138); Diabetic Ketoacidosis (2364)

Event Date 01/30/2022

Event Type  Injury  

Event Description

Customer reported via phone call that they were hospitalized on (b)(6) 2022 due to high blood glucose level and diabetes ketoacidosis. The blood glucose level at the time of hospitalization was unknown. Current blood glucose level was 153mg/dl. Customer was using the insulin pump system within 48 hours of reported high blood glucose event. Customer had experienced symptom related with high blood glucose level including feeling sick or unwell, headache, altered vision. Customer was treated with insulin intravenous drip. The insulin pump 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.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 13421513
• MDR Text Key: 284856954
• Report Number: 2032227-2022-108100
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/09/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2VYCH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 02/02/2022 Patient Sequence Number: 1

Treatment

FRN-MMT-332-RSVR, UNOMED INF SET