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

Model Number MMT-723NAS

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); Nausea (1970); Tachycardia (2095); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 11/27/2019

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that they were hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2019 with blood glucose of over 600 mg/dl.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer stated the insulin pump failed to give her insulin she put a bolus in and it did not deliver the insulin to her body and her sugar went to 573 mg/dl and when she got to the hospital.The customer experienced symptoms such as nausea, vomiting, abdominal pain, difficulty breathing and rapid heartbeat.The customer reported that they allege insulin pump was under delivering.Customer performed displacement test and high pressure test and both test were passed.Customer reported that the drive support cap appears normal.The customer was treated with insulin drip.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 9408212
• MDR Text Key: 169028525
• Report Number: 2032227-2019-126968
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169693814
• UDI-Public: (01)00643169693814
• 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: Other
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: B6723NASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• Date Device Manufactured: 08/10/2018
• 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-UNK-RSVR, UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 164