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

Model Number MMT-7008A

Device Problems Calibration Error (1078); False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 01/27/2018

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.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 Description

The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm, experienced high blood glucose level and change sensor alert.The customer¿s blood glucose was 260 mg/dl and the sensor glucose was 65 mg/dl at the time of the incident.Customer received a change sensor alert after a calibration error.Troubleshoot was performed and the customer stated that insulin delivery was suspended low sensor glucose.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.Customer declined to troubleshoot for high readings.The sensor will not be returned for analysis.

Manufacturer Narrative

Inspected one opened and used sensor.We performed continuity resistance test and sensor passed per specifications.Performed bicarbonate buffer test sensor passed per specifications.

• 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
• MDR Report Key: 7246365
• MDR Text Key: 99181125
• Report Number: 3004209178-2018-48768
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 20643169786725
• UDI-Public: (01)20643169786725(017)20180517
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

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: 05/17/2018
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG253ZS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 55 YR
• Patient Weight: 190