MAUDE Adverse Event Report: MEDTRONIC MINIMED TRANSMITTER MMT-7731 GST3B REPLACEMENT; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7731

Device Problems Defective Component (2292); Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2017

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

(b)(6).Complaint: (b)(4).Complaint status: in process mdt initial contact: (b)(6) taken by: (b)(4) transmitter defect.Test plug: not ok.No connection and communication.No led.Sending replacement.Country: (b)(6) city: (b)(6).Input date: 07/21/2017 warranty start: 00/00/0000 warranty end: 00/00/0000.

Manufacturer Narrative

This event was reported in error.

• Brand Name: TRANSMITTER MMT-7731 GST3B REPLACEMENT
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• 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: 6801939
• MDR Text Key: 83154840
• Report Number: 2032227-2017-37673
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7731
• Device Catalogue Number: MMT-7731
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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