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

Model Number MMT-751NAL

Device Problems Air Leak (1008); Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 06/20/2015

Event Type  Injury  

Event Description

The customer reported via phone call that they had low blood glucose.Customer's blood glucose was 30 mg/dl.The customer treated their blood glucose with liquid glucose.The customer also reported passing out from their low blood glucose incident.Customer also reported they over-bolused for their blood glucose.The customer also reported tiny air bubbles were present on the insulin pump.Troubleshooting shooting found the drive support cap appeared to be normal.The insulin pump also passed a displacement test during troubleshooting.Customer was advised the insulin pump was working as designed.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: 4907050
• MDR Text Key: 15300799
• Report Number: 3004209178-2015-73083
• 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: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• 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: 65 YR
• Patient Weight: 64