MAUDE Adverse Event Report: MEDTRONIC MINIMED CARELINK PERSONAL MMT-7333

Model Number MMT-7333

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2017

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

On (b)(6) 2017 21:34:32 pst ice batch user (batch_ice) (b)(6) (b)(4).Complaint status: in process mdt initial contact: (b)(6) taken by: bazinm2 cx emailed for assistance uploading new 630g pump to carelink personal.Called cx.Cx is using windows 10 with internet explorer.Advised cx to use the contour next link 2.4 as the uplink device.Showed cx how to use internet explorer in administrator mode and install the contour next link 2.4 usb driver.Cx clicked finish but pump communications shut down at 1%.Cx has a contour next link 2.4 without the bayer logo.Advised cx this was an issue we were working on.Advised cx that there is an issue with the interaction between the new contour next link 2.4 meters and carelink personal and taht our softwarew people are working on it.However, i advised cx taht as an interim solution we would ship them a contour meter that would work.Country: (b)(6), input date: (b)(6) 2017 warranty start: (b)(4) warranty end: (b)(4).

Manufacturer Narrative

The initial report for this product was created in error.Please disregard as there is no reportable information.

• Brand Name: CARELINK PERSONAL MMT-7333
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 6959729
• MDR Text Key: 90667002
• Report Number: 2032227-2017-59628
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7333
• Device Catalogue Number: MMT-7333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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