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

Model Number	MMT-751RNAB
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/15/2017
Type of Reportable Event	Malfunction
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.Unit had unresponsive buttons due to flattened (creased) act and esc buttons dome switch.No unlocked j2/lcd keypad connector noted.Unable to perform self-test and displacement test or verify communicate to sensor simulator to confirm lost sensor alarm due to unresponsive button.
Event or Problem Description
The customer reported via phone call that the insulin pump had lost sensor alarm.The customer's blood glucose was 83 mg/dl and 151 mg/dl and 147 mg/dl and 69 mg/dl and 137 mg/dl and 135 mg/dl and 140 mg/dl and 180 mg/dl at the time of incident.The device will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751RNAB
• 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: 8787779
• Report Number: 2032227-2019-29214
• Device Sequence Number: 14112959
• Product Code: OZO
• UDI-Device Identifier: 00643169507968
• UDI-Public: (01)00643169507968
• 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
• Report Date (Section B): 07/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751RNAB
• Device Catalogue Number: MMT-751RNAB
• Device Lot Number: A3751RNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 146