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

Model Number MMT-7008A

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2017

Event Type  malfunction  

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's parent reported via phone call that they had sensor discrepancies.The customer¿s sensor glucose reading from the reported event was 40 mg/dl while their blood glucose reading was 166 mg/dl.Troubleshooting was performed.The customer stated that insulin delivery was suspended due to the low sensor glucose.The sensor glucose that triggered the suspend event was 68 mg/dl when blood glucose was 140 mg/dl.The suspend on low limit in the sensor setting was 70 mg/dl.The sensor will not be returned for analysis.

• Brand Name: SENSOR ENLITE MMT-7008A
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 6976503
• MDR Text Key: 90885168
• Report Number: 2032227-2017-61396
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/25/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 10/25/2017
• 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 Age: 14 YR
• Patient Weight: 76