MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM INSULIN INFUSION PUMP MMT-511NAL; PUMP, INFUSION, INSULIN

Model Number MMT-511NAL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364); Polydipsia (2604)

Event Date 10/07/2019

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

The customer reported via phone call that they were taken to emergency room and then hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2019.Customer¿s blood glucose level was over 500 mg/dl at the time of incident.Customer experienced symptoms such as nausea, vomiting, abdominal pain, difficulty in breathing and they were thirsty.Customer was treated with insulin, potassium and sodium drip.Customer stated that the doctor from the hospital asked her to stop using the insulin pump and they were taken off from insulin pump.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's instructions.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM INSULIN INFUSION PUMP MMT-511NAL
• Type of Device: PUMP, INFUSION, INSULIN
• 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: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219 ; 8185464805
• MDR Report Key: 9551480
• MDR Text Key: 173752566
• Report Number: 2032227-2020-100221
• Device Sequence Number: 1
• Product Code: LZG
• 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: 01/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-511NAL
• Device Catalogue Number: MMT-511NAL
• Device Lot Number: 0000038458
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2019
• 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-326-RSVR, UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Weight: 75