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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP

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ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problems No Display/Image (1183); Moisture Damage (1405); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The pump 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. No conclusions can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a display (damaged w/ moisture) issue. This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission: 12/27/2016. Device evaluation: the device has been returned and evaluated by product analysis on 12/02/2016 with the following findings: during investigation, the pump was returned with moisture visible through the display lens and with scratches on the display lens. A leak test failed due to a crack in the battery compartment. The pump was opened and there was moisture observed throughout the pump casing. The battery compartment was found to be cracked. A leak test was not found at this site.
 
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Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key6093794
MDR Text Key59979146
Report Number2531779-2016-31165
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,Followup
Report Date 10/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age18 MO
Event Location No Information
Date Manufacturer Received10/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2015
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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