MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER MMT-7703NA; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7703NA

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091); Blood Loss (2597)

Event Date 08/22/2016

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Reference manufacturer report number: 2032227-2016-23242.

Event Description

Customer reported via phone call to have gotten an abscess on her arm the size of a nickel due to sensor.Customer reported that the site was cleaned properly prior to insertion.Customer visited healthcare professional who had to cut abscess and drain it.Customer's blood glucose was unknown.The transmitter was also used in conjunction with the sensor.Customer also reported that tape was not sticking correctly.Customer stated that healthcare professional advise to wear sensor in the arm.Customer was advised to speak with healthcare professional regarding alternate sites and irritation.The product will not be returned for analysis.

• Brand Name: MINILINK TRANSMITTER MMT-7703NA
• 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: 6765572
• MDR Text Key: 81779589
• Report Number: 2032227-2017-34022
• 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: Patient
• Type of Report: Initial
• Report Date: 08/03/2017

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 Model Number: MMT-7703NA
• Device Catalogue Number: MMT-7703NA
• Device Lot Number: A000365138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 08/03/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 154