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

Model Number	MMT-751NAH
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/02/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Mdr was created in order to report failure analysis findings: the unit did not have a battery installed when received.Unit passed the displacement test, rewind, basic occlusion test, prime/a33 test, excessive no delivery test and dat test at 0.08720 inches.The stop (idle) current and run current measurement tests are within specification.Unit also passed self test, off no power alarm test and a21 error test.Unit alarmed motor error during the occlusion test due to faulty fsr (gold).The motor was tested outside of the unit and passed.Unit uploaded properly using carelink.Unit had cracked display window, cracked case at display window corner, broken belt clip slot and a partially broken off reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: there is no data available due to the unit did not have a battery installed when received.
Event or Problem Description
Customer's husband reported via phone call that the customer passed away on (b)(6) 2017.The customer had lupis and was hospitalized on (b)(6) 2019.No information was reported on the customer's blood glucose levels or symptoms.The caller did not provide any information about the insulin pump but did return the device back for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAH
• 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; * 00777-3869
• MDR Report Key: 9954100
• Report Number: 3004209178-2020-98677
• Device Sequence Number: 14102442
• Product Code: OZO
• UDI-Device Identifier: 00643169404311
• UDI-Public: (01)00643169404311
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751NAH
• Device Catalogue Number: MMT-751NAH
• Device Lot Number: A2751NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/13/2020
• 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: 47 YR
• Patient Weight: 304