MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR; CGM

Model Number MMT-7002C

Device Problems Loss of Power (1475); Low Sensing Threshold (2575)

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

Event Date 06/20/2014

Event Type  malfunction  

Event Description

It is reported that a customer complained that the sensor connected to their insulin pump implanted in them had a low signal and then shut down after the observation.The patient's blood glucose was not recorded.The product will be returned for analysis.No further information was provided.

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 PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 386
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4022322
• MDR Text Key: 4847252
• Report Number: 3004209178-2014-95809
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2014

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-7002C
• Device Catalogue Number: MMT-7002C
• Device Lot Number: B034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2014
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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