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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 Problem Image Display Error/Artifact (1304)
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 (dim/fading/color spectrum) 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
The device has been returned and evaluated by product analysis on 02/07/2017 with the following findings: during testing, the pump was powered on and the display screen appeared dim and discolored. The complaint was duplicated. Unrelated to the complaint, the battery compartment was observed to be cracked in two places. Additionally, the bolus button cover was observed to be torn; however, the button responded properly to user presses.
 
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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 Key6214952
MDR Text Key63803013
Report Number2531779-2016-35035
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,foreign
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2017
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
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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