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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 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. (b)(6).
 
Event Description
On 01/02/2017, the reporter contacted animas, alleging a casing/condition (cracked/damaged casing- battery compartment) issue. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
 
Manufacturer Narrative
Follow-up #1: date of submission 06/22/2017 device evaluation: the device has been returned and evaluated by product analysis on 06/02/2017 with the following findings: during investigation, the battery compartment was cracked at the threads to the left of the bumper, and at the case seal below the bumper. Unrelated to the original complaint, the display was dim and fading pink. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
 
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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 Key6266718
MDR Text Key65671756
Report Number2531779-2017-01779
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 distributor,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 01/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2017
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 Manufacturer05/26/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age34 MO
Event Location No Information
Date Manufacturer Received01/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2014
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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