MAUDE Adverse Event Report: MEDTRONIC MINIMED GUARDIAN REAL-TIME MONITIOR; CGM

Model Number CSS7100WW

Device Problems No Display/Image (1183); Loss of Data (2903)

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

Event Date 03/29/2015

Event Type  malfunction  

Event Description

It was reported that the device does not have any information recorded in the history.It was stated that the reports were blank after the data was transfer to the computer.The monitor only had 3 hours of graphics.Nothing further 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: GUARDIAN REAL-TIME MONITIOR
• 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: 4730135
• MDR Text Key: 5749706
• Report Number: 2032227-2015-13561
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CSS7100WW
• Device Catalogue Number: CSS7100WW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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