MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 670G INSULIN PUMP MMT-1780KL; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1780KL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Myocardial Infarction (1969)
Date of Event	08/04/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
"this report is part of a retrospective review and remediation efforts in response to a warning letter.Recall: z-0956-2020.(b)(4).S/w 3.18e.Device received with a depleted duracell alkaline battery installed.Device passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and the dat test at 0.08715 inches.Device had a corroded battery tube, scratched case, pillowing keypad overlay and a cracked retainer.Data analysis: (date of customer passing: 8/4/18) 07/29/2018 dailytotalofallinsulindelivered = 194.15.07/30/2018 dailytotalofallinsulindelivered = 159.425.07/31/2018 dailytotalofallinsulindelivered = 38.475.08/01/2018 dailytotalofallinsulindelivered = 73.725.08/02/2018 dailytotalofallinsulindelivered = 55.175.08/03/2018 dailytotalofallinsulindelivered = 0.08/04/2018 dailytotalofallinsulindelivered = 0.
Event or Problem Description
The customer's wife reported via phone call that the customer had passed away on (b)(6) 2018.The cause of the death was heart attack and gastrointestinal bleed.The insulin pump was worn at the time of passing.The insulin pump was returned for analysis.

• Brand Name: 670G INSULIN PUMP MMT-1780KL
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 15038825
• Report Number: 2032227-2022-290214
• Device Sequence Number: 12074353
• Product Code: OZP
• UDI-Device Identifier: 00763000072537
• UDI-Public: (01)00763000072537(17)181028
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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 Expiration Date: 10/28/2018
• Device Model Number: MMT-1780KL
• Device Catalogue Number: MMT-1780KL
• Device Lot Number: HG2H951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0956-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 120 KG