MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problems Partial Blockage (1065); Device Displays Incorrect Message (2591); Material Twisted/Bent (2981)

Patient Problem Bruise/Contusion (1754)

Event Date 09/06/2017

Event Type  Injury  

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 Description

Customer reported via phone call that they experienced insulin flow blocked, when they went to bolus, change this last night insulin flow blocked alarm.The customer¿s blood glucose value was 295 mg/dl at the time of the incident.Customer declined to troubleshoot for high blood glucose.Customer reported the infusion set cannula was crimped.The customer¿s reported that it was hurt when she put it in it ,insulin flow blocked, when she went to bolus, change this last night, when she removed the set , there was a bruise, and it was red, a little knot site issues.The product was not returned for analysis.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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: 6869089
• MDR Text Key: 86321048
• Report Number: 2032227-2017-48516
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169873834
• UDI-Public: (01)00643169873834
• 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
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG1JYN3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2017
• Date Device Manufactured: 12/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 119