MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7040C1

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

Patient Problems Inflammation (1932); Rash (2033); Swelling/ Edema (4577)

Event Date 10/12/2022

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.

Event Description

It was reported that they were hospitalized due to skin issue during sensor wear on (b)(6) 2022.Blood glucose level was unknown when admitted to hospital.Customer was treated with different skin treatments.Customer reported site issue like swelling, rash and inflammation.The device will not be returned for analysis.

• Brand Name: SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1
• 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: 15750049
• MDR Text Key: 303223963
• Report Number: 2032227-2022-356561
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2022

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-7040C1
• Device Catalogue Number: MMT-7040C1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/07/2022
• 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): Hospitalization