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

Model Number MMT-751NAP

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Hyperglycemia (1905); Burning Sensation (2146); Cramp(s) (2193); Urinary Frequency (2275); Diabetic Ketoacidosis (2364)

Event Date 07/29/2015

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.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.

Event Description

The customer reported via phone call that they experienced unexplained high blood glucose over several days.The customer's blood glucose rose to over 500 mg/dl.The customer stated the insulin pump was ineffective with lowering their blood glucose.The customer also reported being hospitalized on (b)(6) 2015.The customer's blood glucose was 600 mg/dl.The customer stated they were frequently urinating with cramps and their eyes were burning.The customer stated the cause of the hospitalization was from diabetic ketoacidosis.The customer was disconnected from the insulin pump and was treated with an iv of insulin and fluids.Troubleshooting found the customer's basal rates were programed inaccurately.Customer stated they would consult with their doctor for their settings.The customer's current blood glucose was 107 mg/dl.The customer declined to return the insulin pump 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5028575
• MDR Text Key: 23972368
• Report Number: 2032227-2015-33937
• 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
• Report Date: 08/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR
• Patient Weight: 71