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

Model Number	MMT-751PNAS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Death (1802); Hypoglycemia (1912)
Date of Event	08/24/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
It was reported via phone call that the customer passed away in an unknown location.The cause of death was at first reported as accidental due to internal bleeding, after a fall and head injury.The caller stated that the customer experienced low blood glucose twice before passing.The first time they tried to get out of bed to treat and twisted her ankles, and the second time, the customer fell, hit her head, and passed away after 2 days.The caller stated that the pump may have been the cause of the customer low and ultimately their passing.The customer did not state whether the customer had any other illnesses that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The customer was most likely wearing the insulin pump at the time of death.It is unknown if the customer was using sensors.The caller declined providing more information about the customer's passing.The caller stated that medtronic should expect contact from their attorney about the customer's death.The caller declined to return the insulin pump for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751PNAS
• 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: 8978454
• Report Number: 2032227-2019-59217
• Device Sequence Number: 14236228
• Product Code: OZO
• UDI-Device Identifier: 00643169507357
• UDI-Public: (01)00643169507357
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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-751PNAS
• Device Catalogue Number: MMT-751PNAS
• Device Lot Number: A3751PNASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVRUNOMED SET
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Weight: 203