MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER; CGM

Model Number MMT-7703NA

Device Problems Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)

Patient Problem Hyperglycemia (1905)

Event Date 09/20/2014

Event Type  malfunction  

Event Description

The customer reported that her blood glucose was 411 mg/dl, which she treated with the insulin pump.The customer stated she was receiving sensor errors after showering or going swimming.The customer stated her high blood glucose may have been a result of underestimating the amount of insulin she needed for her lunch bolus.Troubleshooting was performed for the sensor errors she was receiving and it was found that the transmitter may not have been working.Nothing further was 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: MINILINK TRANSMITTER
• 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: 4185266
• MDR Text Key: 5161026
• Report Number: 2032227-2014-40534
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7703NA
• Device Catalogue Number: MMT-7703NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2014
• Initial Date FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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: 53 YR
• Patient Weight: 89