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

Model Number	MMT-7008B
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspected 1 opened/used sensor and performed continuity resistance test and sensor failed per specification.(b)(4).
Event or Problem Description
The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 137 mg/dl and the sensor glucose was 60 mg/dl at the time of the incident.Blood glucose was 157 mg/dl at the time of the call.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.It was explained to customer the proper insertion techniques and site location.The sensor was returned for analysis.

• Brand Name: SENSOR ENLITE MMT-7008B
• 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: 6855997
• Report Number: 2032227-2017-46667
• Device Sequence Number: 10939376
• Product Code: OZO
• UDI-Device Identifier: 00643169646407
• UDI-Public: (01)00643169646407(017)20171225
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/25/2017
• Device Model Number: MMT-7008B
• Device Catalogue Number: MMT-7008B
• Device Lot Number: HG1X332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 158