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 Detachment Of Device Component (1104); Fracture (1260); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Bruise/Contusion (1754); Blood Loss (2597); Foreign Body In Patient (2687)

Event Date 07/01/2017

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.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 that his sensors were reading improperly and only lasting half of a day.The sensors would prematurely alarm change sensor.The patient's blood glucose at the time of incident is unknown.During troubleshooting the sensor was removed from the customer; it was confirmed that the sensor cannula was detached.The customer could not locate the cannula.The sensor fractured while inside of the customer's body.The sensor will be returned for analysis.

Manufacturer Narrative

Inspected 1 opened/used enlite sensor and found sensor cannula retracted inside sensor base.No broken or missing parts were observed during analysis.Analysis was unable to confirmed customer received sensor in said condition due to customer returned the sensor opened/used.

• 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: 6750856
• MDR Text Key: 81418929
• Report Number: 2032227-2017-31954
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 20643169646432
• UDI-Public: (01)20643169646432(017)20171216
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/16/2017
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG1WNA5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• 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: 43 YR
• Patient Weight: 240