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

Model Number MMT-551LNAS

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Hypoglycemia (1912); Unspecified Infection (1930); Neuropathy (1983); Ischemic Heart Disease (2493)

Event Date 01/23/2017

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, in bed.The caller stated autopsy will be performed; presumed cause of death is cardiac arrest.The customer had neuropathy, vascular disease, heart disease, and infections.The caller stated that the customer suffered from a lot of low blood glucose events.The customer's last recorded blood glucose value was 119 mg/dl on (b)(6) 2017 at 9:30pm, in the bolus history, with 5.7 units of bolus for 46 carbs.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 received with (b)(6) alkaline battery.The insulin pump passed all functional testing including idle current measurement test, run current measurement test, self-test, off no power test, unexpected restart error test, displacement test, basic occlusion test, occlusion test, prime test, rewind test and excessive no delivery test.The insulin pump passed the displacement accuracy test.However, the insulin pump was received with intermittent act and up button response; unable to determine root cause due to insulin pump preservation.The insulin pump had cracked reservoir tube lip and minor scratched lcd window.Data analysis: there is no data listed for the dated of (b)(6) 2017 due to the insulin pump was received with a depleted battery installed.

• 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: 6302564
• MDR Text Key: 66546361
• Report Number: 3004209178-2017-87105
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAS
• Device Catalogue Number: MMT-551LNAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Date Manufacturer Received: 05/05/2017
• 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: 70 YR
• Patient Weight: 79