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

Model Number	9438-05
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2018 that the display device showed a transmitter failed error on (b)(6) 2018.The device has been received for investigation.A follow-up will be submitted upon completion of device investigation.No additional patient or event information is available.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The transmitter has been received for evaluation.An external visual inspection was performed and passed.Voltage testing was performed and passed as the transmitter has voltage.A transmitter functional test was performed and passed.No share log data was available for review.The complaint confirmation of a transmitter failed error could not be determined.A probable cause could not be determined.No additional patient or event information is available.

• Brand Name: ANIMAS VIBE SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 7404536
• Report Number: 3004753838-2018-035684
• Device Sequence Number: 1963396
• Product Code: OYC
• UDI-Device Identifier: 40386270000048
• UDI-Public: 40386270000048
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/04/2018
• Device Model Number: 9438-05
• Device Catalogue Number: STT-RX-001
• Device Lot Number: 5226974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR