MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER; CGM

Model Number MMT-7703NA

Device Problems High Test Results (2457); Device Sensing Problem (2917); Moisture or Humidity Problem (2986)

Patient Problem Hyperglycemia (1905)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that the customer experienced a high blood glucose level of 475 mg/dl.It was also reported that the customer received a sensor error on his insulin pump, following the transmitter being exposed to water in a swimming pool for two hours.The transmitter was found not to be functioning properly as the lights on it would not blink.The customer treated his high blood glucose with his insulin pump and went down to 383 mg/dl.Nothing further was reported.

Manufacturer Narrative

The transmitter was unable to charge due to broken pins.Functional testing was not possible to perform due to charge anomaly.The unit was received with contamination on all pins, as well as a broken pin.

• 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: 3971090
• MDR Text Key: 4753789
• Report Number: 2032227-2014-04938
• 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: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 18 YR