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

Model Number MMT-551NAP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)

Event Date 04/05/2016

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 had high and low blood glucose but not hospitalized. Customer's blood glucose at time of incident was 417 mg/dl. Customer stated that she needs a new infusion set and reservoir because she is going to change and use different insulin. Customer stated that she took a lot of insulin and went low. The customer declined to troubleshoot because she feels it has to be the insulin. The customer high blood glucose was documented and shipped and replacement supplies.

• 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: 5602795
• MDR Text Key: 43493032
• Report Number: 3004209178-2016-42979
• 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: 04/06/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/23/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• 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: 04/06/2016
• 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: 04/23/2016 Patient Sequence Number: 1