MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7040C2 GUARDIAN4 5PK OUS 2; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7040C2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Itching Sensation (1943); Rash (2033)

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported that the customer was hospitalized due to rashes under the oval adhesive in the beginning of (b)(6) 2022.Customer stated that the skin was red, itchy and very sore.Customer stated that there was allergic reaction on tummy and chest.Customer was treated with antispetic cream and allergy medicine.No further complications were reported.Customer will continue to use the sensor.

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.

• Brand Name: SENSOR MMT-7040C2 GUARDIAN4 5PK OUS 2
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 13657362
• MDR Text Key: 287690977
• Report Number: 2032227-2022-119982
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7040C2
• Device Catalogue Number: MMT-7040C2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2022
• 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 Outcome(s): Other