MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER; CGM

Model Number MMT-7703NA

Device Problems Device Operates Differently Than Expected (2913); Moisture or Humidity Problem (2986)

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Date 12/11/2014

Event Type  Injury  

Manufacturer Narrative

The transmitter was unable to charge due to a broken pin.The functional tests could not be performed due to the charge anomaly.The transmitter was received with contamination an all pins.

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.

Event Description

It was reported that the customer's blood glucose was 500 mg/dl and the transmitter fell into the bath tub without the sensor connected to it, and no longer seemed to be working.Customer also reportedly had another high blood glucose event when she was vomiting.Nothing further reported.

• 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: 4405690
• MDR Text Key: 12796139
• Report Number: 2032227-2015-01183
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/17/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 01/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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: 9 YR
• Patient Weight: 27