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

Model Number MMT-751NAS

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Overdose (1988)

Event Date 06/18/2015

Event Type  Injury  

Event Description

The customer reported via phone call that they experienced high blood glucose.The customer stated their blood glucose rose to 500 mg/dl.Customer stated they attempted to treat their blood glucose with boluses and an insulin pen, but their blood glucose would not decline.Customer's current blood glucose was 72 mg/dl.Troubleshooting found the insulin pump passed a high pressure test the second time it was performed.Customer was advised to change out their entire infusion set, reservoir, and insulin.The customer also reported their blood glucose was low from programming too much insulin to their body.The customer declined to troubleshoot for their low blood glucose.The customer declined to return the insulin pump for analysis.

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.

• 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 386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 386
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4904125
• MDR Text Key: 17542845
• Report Number: 3004209178-2015-73038
• 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: 06/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2015
• 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): Other
• Patient Age: 63 YR
• Patient Weight: 77