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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. ANIMAS VIBE; OYC
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DEXCOM INC. ANIMAS VIBE; OYC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to animas.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusion can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging there was blood at the site when the sensor was inserted.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in injury and/or require medical intervention.
 
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Brand Name
ANIMAS VIBE
Type of Device
OYC
Manufacturer (Section D)
DEXCOM INC.
6340 sequence dr
san diego CA 92121 4356
Manufacturer (Section G)
DEXCOM INC.
6340 sequence dr
san diego CA 92121 4356
Manufacturer Contact
6340 sequence dr
san diego, CA 92121-4356
MDR Report Key5728159
MDR Text Key47509943
Report Number2531779-2016-12033
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 Patient
Type of Report Initial
Report Date 06/01/2016
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
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 06/01/2016
Initial Date FDA Received06/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age57 YR
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