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

Model Number MMT-723RNAS

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

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); No Code Available (3191)

Event Date 07/01/2019

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer's family reported via phone call that they were hospitalized due to unconsciousness, diabetic ketoacidosis and cardiac arrest glucose on (b)(6) 2019 with blood glucose was unknown and customer also experienced high blood glucose.Customer¿s blood glucose level was 600 mg/dl at the time of incident.Customer has been using insulin pump system within 48 hours of reported high blood glucose.The customer did experienced the symptoms such as diarrhea, nausea, vomiting and had cardiac arrest for 10 minutes and brain damage as a result.Customer was treated with electrocardiogram, magnetic resonance imaging, x-rays, bear hug for warmth, had to slowly bring blood glucose back down, intravenous insulin and heparin for the heart.It was also stated that the insulin pump was not working and buttons were sticking.Bases on report customer was alleging that the insulin pump was under delivering.Trouble shooting was performed for under delivering.Customer was advised to performed displacement test and test was passed.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS
• 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: 8968227
• MDR Text Key: 156712747
• Report Number: 2032227-2019-57541
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513143
• UDI-Public: (01)00643169513143
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Device Lot Number: A1723RNASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Date Device Manufactured: 09/15/2015
• 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-332-RSVR,UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 200