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

Model Number MMT-551NAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Fever (1858); Hyperglycemia (1905); Hypoglycemia (1912); Pneumonia (2011); Brain Injury (2219)

Event Date 07/08/2016

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.A request to return the device has been made and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.Please see medwatch report 3004209178-2016-60370.

Event Description

It was reported that the customer was hospitalized on (b)(6) 2016.The customer had an issue with the insulin pump on (b)(6) 2016 and disconnected from the device.The caller stated that prior to disconnecting from the device, the customer was struggling with high and low blood glucose.On 06/20/2016 the customer reported the device issue.On (b)(6) 2016, the customer experienced low blood glucose, was unresponsive, was hospitalized, and was placed on a feeding tube.The customer passed away on (b)(6) 2016, in a hospital.The customer had a brain injury and pneumonia.The caller stated that upon admission to the hospital on (b)(6) 2016, the customer had fever.The caller did not know the customer's blood glucose at the time of death.The customer was not wearing the insulin pump at the time of death; it had been discounted eighteen days prior to passing.The customer disconnected the insulin pump and was treating with manual injections.The pump will return for analysis.

Manufacturer Narrative

It was reported by the deceased customer's sister (b)(6) they never received an official cause of death but did mention that the customer was in a coma at the time of their passing.

• 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: 5865669
• MDR Text Key: 51762248
• Report Number: 3004209178-2016-63617
• 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,Followup
• Report Date: 08/12/2016

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-551NAL
• Device Catalogue Number: MMT-551NAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• 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: 38 YR
• Patient Weight: 76