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

Model Number	MMT-751NAS
Medical Device Problem Codes	Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Death (1802); Hyperglycemia (1905)
Date of Event	10/02/2017
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
Medtronic legal received information regarding the customer¿s passing from the attorney of the family.The information received on march 9, 2020 stated the customer's next of kin had filed a legal suit.The amended petition alleges that the minimed 530g pump system caused the customer's passing in that it failed to deliver or delivered an inadequate amount of insulin causing him to become hyperglycemic, and that no alarms were triggered to alert the customer of this before they passed.The next of kin had previously spoken with medtronic and stated the customer's cause of death was pending the medical examiner's findings, and that the caller was unsure if the customer was wearing the pump at the time of passing.Frn-unk-rsvr, unomed set.
Additional Manufacturer Narrative
Additional information has been received which was not included with the initial report.The information has been provided with this report: the customer had a blood glucose reading of over 600 mg/dl.The customer was wearing the pump at the time of passing, and the pump became lost after the next of kin received the customer's personal belongings.(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
The customer had a blood glucose reading of over 600 mg/dl.The customer was wearing the pump at the time of passing, and the pump became lost after the next of kin received the customer's personal belongings.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• 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: 10533173
• Report Number: 2032227-2020-176706
• Device Sequence Number: 4092873
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• 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,Followup
• Report Date (Section B): 09/15/2020

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-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 09/15/2020
• 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-RSVR, UNOMED SET.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 34 YR