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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 Image Display Error/Artifact (1304); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The pump was returned for investigation and device evaluation was completed by product analysis on 12/12/2016 with the following findings. Bumper/grip pads are intact and undamaged. Keypad cover lifted at ok button; all buttons responsive during investigation. Removed cover; no contamination under contacts. Display is dim/fading (pink). Crack between case seal and keypad cover; crack between case seal and display lens corner. Battery compartment crack at case seal below the bumper. (b)(6).
 
Event Description
There was no adverse event associated with this complaint. The pump was returned for product analysis investigation and the evaluation revealed a cracked compartment and dim display. This report is made based on the results of an investigation completed on (b)(6) 2016.
 
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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 Key6228637
MDR Text Key64429915
Report Number2531779-2017-00465
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
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 12/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2017
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 Age35 MO
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2014
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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