MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM TRANSLATOR UNIVERSAL

Model Number MMT-7018NAU

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2017

Event Type  malfunction  

Manufacturer Narrative

Unit charge properly and no led anomalies were noted.However, unit failed to communicate during testing, problem isolated to electronic assembly.

Event Description

The customer reported via phone call that the uploader was not charging.Customer had tried using different usb, outlets and was not carrying a full charge at all so getting the uploader replaced.The device will be returned for analysis.

• Brand Name: PARADIGM TRANSLATOR UNIVERSAL
• 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 ; 8185464805
• MDR Report Key: 8385654
• MDR Text Key: 137969259
• Report Number: 2032227-2019-01886
• Device Sequence Number: 1
• Product Code: MDS
• 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: 03/04/2019

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 Expiration Date: 07/18/2017
• Device Model Number: MMT-7018NAU
• Device Catalogue Number: MMT-7018NAU
• Device Lot Number: 840114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 224