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U.S. Department of Health and Human Services

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

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DEXCOM, INC. ANIMAS VIBE SYSTEM CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 9438-05
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that the display device showed a transmitter failed error on (b)(6) 2018. The complaint device was returned for evaluation. The device was visually inspected, and no defect was found. Voltage testing was performed, and the test failed. A review of the downloaded data log did not confirm the reported event of failed transmitter error. A probable cause could not be determined. No additional patient or event information is available.
 
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Brand NameANIMAS VIBE SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key8027905
MDR Text Key125957645
Report Number3004753838-2018-134033
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 10/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/06/2019
Device Model Number9438-05
Device Catalogue NumberSTT-GL-003
Device Lot Number5240733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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