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 Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/30/2017
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that her blood glucose levels have been going up and down and she was having sensor with inaccurate readings.The customer's blood glucose reached 500 mg/dl on (b)(6) 2017.The customer's blood glucose at the time of the call was 240 mg/dl.The customer stated that she moves around a lot during her sleep and her infusion sets rip off her insertion site.The customer stated that she treated her high blood glucose with insulin pump but she went low, so she treated with manual injections instead.The customer also reported discrepancies in sensor readings that triggered threshold suspend.Blood glucose was 239 mg/dl and sensor glucose was 40 mg/dl or below.Customer did not troubleshoot for high blood glucose.No product was 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
• MDR Report Key: 7843652
• Report Number: 2032227-2018-22699
• Device Sequence Number: 13814330
• Product Code: OZO
• UDI-Device Identifier: 20643169646432
• UDI-Public: (01)20643169646432(017)20170815
• 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): 09/04/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/15/2017
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG1NURY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNKNOWN-RESERVOIR UNOMEDICAL INFUSION SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 160