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

Model Number	9438-05
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a loss of connection occurred.No data was provided for evaluation.Confirmation of the issue was undetermined.The probable cause could not be determined.The device has been received for investigation.A follow up will be submitted upon completion of device investigation.No additional event or patient information is available.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The transmitter was returned for evaluation.External visual inspection was performed and passed.A voltage test was performed and passed.The global transmitter final functional test was performed and passed.A pairing test with the (b)(6) bluetooth device was performed and passed.The data file was reviewed and there was no data available.The reported customer complaint was not confirmed because the device passed the functional testing.The reported allegation was not found.

• 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: 7346808
• Report Number: 3004753838-2018-027145
• Device Sequence Number: 1220688
• Product Code: OYC
• UDI-Device Identifier: 40386270000048
• UDI-Public: 40386270000048
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/14/2018

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: 05/05/2018
• Device Model Number: 9438-05
• Device Catalogue Number: STT-RX-001
• Device Lot Number: 5229974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR