MAUDE Adverse Event Report: DEXCOM, INC. ANIMAS VIBE SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 9438-05

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2019, that on (b)(6) 2019, a "call service error code" occurred.No additional patient or event information is available.No product or data were provided for evaluation.The complaint confirmation could not be determined.A root cause could not be determined.

• Brand Name: ANIMAS VIBE SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8401035
• MDR Text Key: 138147149
• Report Number: 3004753838-2019-23990
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-05
• Device Catalogue Number: STT-GL-004
• Device Lot Number: 5242558
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1