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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. ANIMAS VIBE INSULIN INFUSION PUMP

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DEXCOM INC. ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Hypoglycemia (1912); Dizziness (2194)
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to animas for evaluation. If the device is returned, an evaluation shall be completed and a supplemental report will be filed.
 
Event Description
On (b)(6) 2016, the patient contacted animas and alleged having a blood glucose of bg of 57mg/dl with severe dizziness/wooziness, and that the pump didn't warn of a low blood sugar. During troubleshooting, customer support found that the patient had just ended the 2 hour startup for cgm and had not yet calibrated. Customer support attributed the bg excursion to training misuse. This complaint is being reported as the patient experienced hypoglycemia related to the calibration not being performed.
 
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Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
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 Key5896648
MDR Text Key52769454
Report Number2531779-2016-22484
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 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID Number1-MCBC-3760
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 Received08/01/2016
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

Patient Treatment Data
Date Received: 08/23/2016 Patient Sequence Number: 1
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