MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP OZO

Model Number MMT-751NAS

Device Problem Air Leak (1008)

Patient Problems Dehydration (1807); Fatigue (1849); Hyperglycemia (1905); Blurred Vision (2137); Urinary Frequency (2275); Palpitations (2467)

Event Date 03/20/2017

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

The customer reported via phone call that they were hospitalized on (b)(6) 2017 due to dehydration and high blood glucose. The customer was at the airport when she began feeling tired and her heart beat was going really fast so they had called the hospital. The customer's blood glucose level at the time of admission was 526 mg/dl. The customer was wearing the insulin pump at the time of the hospitalization. The customer had symptoms of being dehydrated, blurry vision, and going to the restroom a lot. Her high blood glucose was treated with a syringe and a bottle of insulin. It was noted during troubleshooting that there were two air bubbles along the tubing length. The customer was able to clear out the air bubbles. There were no leaks. The customer had already changed the set 4 times at the hospital. The customer will continue to monitor the insulin pump. The device will not return for analysis.

• Brand Name: 530G INSULIN PUMP
• Type of Device: OZO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6509859
• MDR Text Key: 73331699
• Report Number: 3004209178-2017-46411
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/20/2017 Patient Sequence Number: 1