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

Model Number MMT-751NAB

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Fall (1848); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Polydipsia (2604)

Event Date 12/26/2016

Event Type  Death  

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.

Event Description

It was reported that the customer passed away at home.The cause of death was complications from diabetes, hypertension, hyperlipidemia, copd.The caller stated that the night prior to passing, the customer was not feeling well, had a back ache and was thirsty.In the morning of passing, the customer was thirstier but did not want paramedics to be called, drank a few sips of juice and his head dropped; he passed away.The customer had sinus infection, fell on an iron pipe, went to a doctor, and fell three more times after that - prior to passing.The customer was put on muscle relaxers.The caller stated that they were unsure, but, the morning of passing, the customer's blood glucose was either 306 mg/dl or 316 mg/dl.The customer was wearing the insulin pump at the time of death.The customer was not using sensors.The caller agreed returning the insulin pump for analysis.

Manufacturer Narrative

The insulin pump was returned without a battery installed.The insulin pump passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement accuracy test.The insulin pump had cracked reservoir tube lip.Data analysis: there is no data available due to the insulin pump did not have a battery installed when received.

• 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: 6514346
• MDR Text Key: 73448027
• Report Number: 3004209178-2017-46325
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 45 YR
• Patient Weight: 77