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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Hypoglycemia (1912); Ambulation Difficulties (2544)
Event Type  No Answer Provided  
Manufacturer Narrative
The pump has not been returned to animas. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas and alleged that the patient had a blood glucose of 65 mg/dl with unsteadiness when walking. Treatment included fast acting glucose. During troubleshooting, customer support found that the patient had received a sensor error #1 and could not recalibrate. The patient had not yet followed the action steps of waiting one hour and recalibrating, so customer support educated them. This complaint is being reported as the patient experienced hypoglycemia related to use error.
 
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Brand NameANIMAS VIBE
Type of DeviceOYC
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 Key5833043
MDR Text Key50737027
Report Number2531779-2016-18036
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 07/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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