MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751NAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/30/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The insulin pump was received with a depleted energizer industrial alkaline battery installed.The insulin pump passed the displacement test, rewind, basic occlusion test, self test and a21 error test.The stop (idle) current and run current measurement tests are within specification.The pump also passed off no power alarm test and the dat test at 0.08790 inches.The pump was unable to prime during prime test.Unable to determine the root cause of the prime anomaly due to pump preservation.The pump was unable to perform the occlusion test and excessive no delivery test due to prime anomaly.The pump had a scratched reservoir tube window and a cracked reservoir tube lip.Data analysis: there is no data available due to the unit received with a depleted battery installed.
Event or Problem Description
It was reported that the customer passed away at home on (b)(6) 2018.The cause of death was unknown.The caller stated that the customer¿s neuropathy may have led to their passing.The customer¿s blood glucose was unknown at the time of death.The customer was wearing the insulin pump at the time of death.It is unknown if the customer used sensors.The insulin pump was returned for analysis.
Additional Manufacturer Narrative
The aware date provided with the initial report was incorrect.The correct information has been provided with this report.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7895427
• Report Number: 2032227-2018-31228
• Device Sequence Number: 10800176
• Product Code: OZO
• UDI-Device Identifier: 00643169736085
• UDI-Public: (01)00643169736085
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A6751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 40 YR