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	09/01/2017
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
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 121 mg/dl and the sensor glucose was 46 mg/dl at the time of the incident.The customer stated he had false readings and also shutoff in the middle of the night suspended.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.The product will be replaced.The product will be returned for analysis.
Additional Manufacturer Narrative
Inspected one opened/used sensor and performed continuity resistance test and sensor passed.Performed bicarbonate buffer test and sensor passed per specifications.

• 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: 6874020
• Report Number: 2032227-2017-49524
• Device Sequence Number: 1221524
• Product Code: OZO
• UDI-Device Identifier: 00643169646407
• UDI-Public: (01)00643169646407(017)20180131
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/04/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Model Number: MMT-7008B
• Device Catalogue Number: MMT-7008B
• Device Lot Number: HG1ZL9R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Initial Date Received by Manufacturer: 09/02/2017
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 04/04/2018
• 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: 55 YR
• Patient Weight: 130