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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED CARELINK WEB UPLOADER; CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE

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MEDTRONIC MINIMED CARELINK WEB UPLOADER; CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE Back to Search Results
Model Number ACC-7350
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Manufacturer Narrative
Select patient information cannot be provided due to regional privacy regulations.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, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
Information received by medtronic indicated that the customer was not able to upload their insulin pump data to carelink.Troubleshooting was performed but issue could not be resolved.No harm requiring medical intervention was reported.It was unknown if the customer will discontinue using the device or not.The product will not be returned for analysis.
 
Manufacturer Narrative
After a thorough investigation the software support team confirmed through database application logs that the clinic had intermittent upload failures as described by helpline.Also, that upload failures were occurring during two different upload stages the first while updating authorities and the other during unsubscribe to notification indication.Both of these errors would usually indicate a network issue.However an incorrect driver version could also produce these errors.Provided the following troubleshooting details to helpline: confirm if the clinic utilizes a proxy server.Determine if this issue is present across all pumps or only specific ones.The observed behavior suggests a potential network issue.They suspect a driver problem, likely an incompatible one.Sometimes, windows update may update one of the drivers installed by the uploader.According to logs, it seems that silicon labs driver was updated.They can try outlined steps below to troubleshoot and hopefully resolve the issue.Run one of these exes as admin (ftdi is more common) c:\program files\medtronic\carelink\uploader\dss\drivers\usb\ftdi-driver\dp-chooser.Exe ftdi or c:\program files \ medtronic \ carelink \ uploader\ dss\ drivers\ usb\cp210xvcp\ cp210xvcpinstaller_x64.Exesilicon labs this will reinstall the blue adapter's driver.Once it's reinstalled, check device manager for ports > usb serial port.If this doesn¿t work follow the steps below: request the user to connect the link device/blue adapter to a different usb port and wait 30 seconds for link device/blue adapter to be recognized advise the customer to select try again after connecting to each available usb port on computer to determine if the link device is found use device manager to determine if the computer is detecting the usb link device/blue adapter for blue adapter: if blue adapter is incorrectly being detected under other devices as cs3910a right-click cs3910a and select uninstall device uninstall device dialog box will display delete the driver software for this device option and click uninstall button go to settings app > devices under other devices section, look for cs3910a and remove cs3910a it unplug blue adapter, restart computer and reinstall carelink uploader if it is still undetected, if possible, try this on another computer and see if the same thing happens.If the problem follows the adapter, it should be replaced i believe the driver reinstalls stop working because the getting updated automatically probably by windows.All the recent logs contain same error.Incompatible driver: {description=silicon labs cp210x usb to uart bridge, manufacturer=silicon laboratories inc, provider=silicon laboratories inc., version=11.3.0.176}.Ble dongle incompatible driver: {vid=10c4, pid=ea60} the hospital may need to disable driver updates locally on the affected machines or through a group policy.For reference carelink uploader uses the silicon labs driver version 10.1.10.103 here is the latest ip for pow but it may change, we recommend to use the domain names.Name: carelink.Medtronic.Eu address: 144.15.107.35 the software successfully adhered to the specified requirements and performed in accordance with expectations specified in the 10542712doc_z, version pch00113968.Root cause: most likely due to local network restrictions (firewall etc.) we are proceeding to close this ticket as we have not received any response.If the reported issue is still ongoing, kindly request you to open a new svn and create a new jira ticket, providing the updated information as requested.This will allow us to address the matter promptly and efficiently.Afc code: fb35af other device setting issue 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.
 
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Brand Name
CARELINK WEB UPLOADER
Type of Device
CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE
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 Key18883660
MDR Text Key337454581
Report Number2032227-2024-140226
Device Sequence Number1
Product Code PHV
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/13/2024
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 NumberACC-7350
Device Catalogue NumberACC-7350
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/27/2024
Initial Date FDA Received03/12/2024
Supplement Dates Manufacturer Received04/09/2024
Supplement Dates FDA Received08/14/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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