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

Model Number MMT-751NAL

Device Problem Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Date 01/11/2016

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's mother reported via phone call of issues with customer's high blood glucose levels.The customer's blood glucose level was reported to be 600mg/dl.The mother states there was an incident where the device delivered only 1 unit of insulin and shows having delivered 13 units on previous occasions.The mother states there were no alarms.The mother states they treated with the help of their healthcare provider.The mother states they adjusted the vassal rate and changed out the set.The mother refused to troubleshoot for the highs.The mother also states of incident where meter was reading 75mg/dl, and the sensor was reading 58mg/dl.The caller states there were no low alerts.The pump was not present at the time, so troubleshoot could not be conducted.The mother was advised to call back when pump is available, in order to troubleshoot.

• 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: 5403060
• MDR Text Key: 37275473
• Report Number: 3004209178-2016-84370
• 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: other
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/01/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR
• Patient Weight: 32