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

Model Number MMT-551NAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Brain Injury (2219); Loss of consciousness (2418)

Event Date 10/09/2016

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.(b)(4).

Event Description

It was reported via phone call that customer was found unconscious and was taken to the hospital via ambulance on (b)(6) 2016.Customer's blood glucose was unknown.It was reported that customer suffered brain damage, but it was not yet known to what extent.Caller reported that insulin pump had no batteries or battery cap.Troubleshooting could not be performed on insulin pump due to not having batteries.Caller requested for battery cap to be replaced.

• 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: 6040875
• MDR Text Key: 57857879
• Report Number: 2032227-2016-32981
• 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: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAL
• Device Catalogue Number: MMT-551NAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2016
• 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): Hospitalization
• Patient Age: 28 YR