• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SOFTWARE CSS7200 GRDN IOS APP; SENSOR, GLUCOSE, INVASIVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MINIMED SOFTWARE CSS7200 GRDN IOS APP; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number CSS7200
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2024
Event Type  malfunction  
Event Description
It was reported to medtronic minimed that the customer experienced communication issue with the transmitter and mobile device.The customer reported no adverse event.The event involved product(s) css7200, mmt-7821lna.The troubleshooting was partially performed and issue was not resolved.Unable to complete troubleshooting or provide instructions, insufficient information to escalate.No harm requiring medical intervention was reported.No product return is required for css7200.No product return is required for mmt-7821lna.
 
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.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOFTWARE CSS7200 GRDN IOS APP
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
lusine boyadzhyan
18000 devonshire st.
northridge, CA 91325
MDR Report Key19210949
MDR Text Key341356517
Report Number2032227-2024-161034
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/29/2024
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 NumberCSS7200
Device Catalogue NumberCSS7200
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/15/2024
Initial Date FDA Received04/30/2024
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Age59 YR
Patient SexFemale
-
-