MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723LNAS

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

Patient Problems Hematoma (1884); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 12/31/2021

Event Type  Injury  

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.

Event Description

The customer reported via phone call that they were in emergency room due to high blood glucose on (b)(6) 2021 for some hours with blood glucose level which was unknown.The customer blood glucose level was over 400 mg/dl.The customer was treated with manual injection.The blood glucose level went high again after coming from emergency room.Customer stated that they had knot under the skin so blood glucose level went high.Customer reported symptoms of nausea and vomiting as they were feeling sick.Customer was not assisted for troubleshooting.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
• 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: 13148741
• MDR Text Key: 283164081
• Report Number: 2032227-2022-100459
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000161132
• UDI-Public: (01)000000763000161132
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Device Lot Number: A7723LNASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2022
• Date Device Manufactured: 10/17/2018
• 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
• Treatment: FRN-MMT 332A-RSVR, UNOMED SET.
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male