MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER; CGM

Model Number MMT-7703NA

Device Problems Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896); Temperature Problem (3022)

Patient Problem Hypoglycemia (1912)

Event Date 01/12/2015

Event Type  Injury  

Event Description

It was reported that the customer had issues with the continuous glucose monitoring system connecting to the pump.Customer had a lost sensor alert.Customer was advised that the serter seems like the spring was getting old.Customer had to try several times to get the sensor in.Customer stated that the radio frequency communication was not established.Customer stated that the transmitter led did not blink on and off for 10 seconds.Customer was advised that the minilink may not be working.It was possible that the transmitter was not holding a charge.Customer reset everything last night and set up a new sensor.Customer's recent blood glucose reading was 47 mg/dl.No further assistance needed.

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.Reference manufacturer report number: 3004209178-2015-87910.

• 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: 4455191
• MDR Text Key: 16457522
• Report Number: 2032227-2015-03874
• 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: Other
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• 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
• Device Lot Number: A000275378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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: 30 YR
• Patient Weight: 76