MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-XXX

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

Patient Problems Dehydration (1807); Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

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

It was reported that they were hospitalized due to high blood, glucose vomiting and dehydration on (b)(6) 2021, with blood glucose of 503 mg/dl.The customer was treated with intravenous drip and manual injection.Customer reported other symptoms with high blood glucose were dehydration and vomiting.Customer was diagnosed with diabetic ketoacidosis.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer was not using automode feature at time of incidence.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325-1219 ; 7635140379
• MDR Report Key: 12266600
• MDR Text Key: 264716084
• Report Number: 2032227-2021-175683
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2021
• 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: UNOMED INF SET, FRN-UNK-RSVR,
• Patient Outcome(s): Other