MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-7008A
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
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
Customer reported via phone call that they experienced low blood glucose level.Customer's blood glucose value was 49 mg/dl at the time of the incident.The customer also stated that sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 161 mg/dl and the sensor glucose was 54 mg/dl at the time of the incident.Low limit setting was 80 mg/dl.The customer¿s other blood glucose was 179 mg/dl, 173 mg/dl and the customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.The customer was assisted with troubleshooting and declined for low blood glucose.The device will not be returned for analysis.

• Brand Name: SENSOR ENLITE MMT-7008A
• 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: 10100380
• Report Number: 2032227-2020-124105
• Device Sequence Number: 14116892
• Product Code: OZO
• UDI-Device Identifier: 20643169786725
• UDI-Public: (01)20643169786725(17)200722(10)HG41CFT
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/22/2020
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG41CFT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 05/29/2020
• 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: Other
• Patient Age: 73 YR
• Patient Weight: 73