MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008B; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-7008B
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose value was 14.6 mmol/l and the sensor glucose was 5.1 mmol/l.Insulin delivery was suspended due to sensor values.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.Customer states high blood glucose treated with bolus.Customer declined troubleshooting for high blood glucose.The sensor will not be returned for analysis.

• Brand Name: SENSOR ENLITE MMT-7008B
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8398433
• Report Number: 2032227-2019-02039
• Device Sequence Number: 10826277
• Product Code: OZO
• UDI-Device Identifier: 00643169786738
• UDI-Public: (01)00643169786738(17)190518(10)K198P
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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 Expiration Date: 05/18/2019
• Device Model Number: MMT-7008B
• Device Catalogue Number: MMT-7008B
• Device Lot Number: K198P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1