MAUDE Adverse Event Report: MEDTRONIC MINIMED SFTWR, CSS7201 GUARDIAN ANDROID APP; GLUCOSE OXIDASE, GLUCOSE

Model Number CSS7201

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2021

Event Type  malfunction  

Event Description

Medtronic received information that no communication (unresolved) occurred.There was no adverse impact or consequence reported as a result of this event.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.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: SFTWR, CSS7201 GUARDIAN ANDROID APP
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• 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: 13783797
• MDR Text Key: 297413883
• Report Number: 2032227-2022-141530
• Device Sequence Number: 1
• Product Code: CGA
• 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: 03/15/2022

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 Model Number: CSS7201
• Device Catalogue Number: CSS7201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 52 YR
• Patient Weight: 180