MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR; CGM

Model Number MMT-7002C

Device Problems Component Falling (1105); Communication or Transmission Problem (2896); Device Sensing Problem (2917)

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

Event Date 06/14/2014

Event Type  malfunction  

Manufacturer Narrative

A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

Event Description

Customer reported lost sensor alerts.Customer stated that the wrong transmitter id was not programmed in the insulin pump.She stated that the insulin pump was not communicating with the transmitter.The lost sensor alert was reoccurring.Customer found that the lost sensor alarm occurred due to the sensor falling out.The blood glucose reading was 149 mg/dl.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.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.

• Brand Name: SENSOR
• 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: 3933438
• MDR Text Key: 12774961
• Report Number: 2032227-2014-03872
• 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,Followup
• Report Date: 06/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7002C
• Device Catalogue Number: MMT-7002C
• Device Lot Number: L213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 62 YR
• Patient Weight: 57