MAUDE Adverse Event Report: MEDTRONIC MINIMED CARELINK PERSONAL CGMS SOFTWARE

Model Number MMT-7333

Device Problem Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

It was reported that the customer had issues with boluses not showing up on carelink reports upon uploading information from the insulin pump.The blood glucose reading was 19 mmol/l, which was treated using the insulin pump.The caller stated that she had noticed the issue while at the hospital to upload the insulin pump into the hospital's system.She stated that she had not uploaded the device to carelink personal and was no longer at the hospital.She was advised that the hospital would need to call in order to proceed with troubleshooting.She was advised to upload the device to carelink personal for reference and to call back once done.Nothing further reported.

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.

• Brand Name: CARELINK PERSONAL CGMS SOFTWARE
• Type of Device: CGM
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4281444
• MDR Text Key: 5035524
• Report Number: 2032227-2014-58405
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• 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: 10/28/2014
• 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