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

Model Number MMT-7008A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Hypoglycemia (1912)

Event Date 06/13/2017

Event Type  Injury  

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 Description

The customer reported via phone call that they were experiencing low blood glucose level and sensor issues.Blood glucose level at the time of the incident was 41 mg/dl which was treated with food.Customer also stated that they were getting sensor with inaccurate readings that triggered threshold suspend alarm.Blood glucose was 88 mg/dl and sensor glucose was 44 mg/dl.Customer declined to troubleshoot for low blood glucose.The insulin pump/ sensor was not replaced nor returned for analysis.

• Brand Name: SENSOR ENLITE MMT-7008A
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 7663082
• MDR Text Key: 113156881
• Report Number: 3004209178-2018-88224
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 20643169646432
• UDI-Public: (01)20643169646432(017)20171020
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2017
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG1T8A9
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 166