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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 Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 (b)(6) 2016, the reporter contacted animas, alleging a casing issue.It was alleged that the cartridge compartment was cracked.There was no allegation of an adverse event associated with this complaint.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 cartridge compartment.
 
Manufacturer Narrative
Follow-up #1 date of submission 09/06/2016 device evaluation: the pump has been returned and evaluated by product analysis on 08/10/2016 with the following findings: a visual inspection of the pump showed that the battery compartment and cartridge compartment were cracked.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 Name
ANIMAS VIBE
Type of Device
INSULIN 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 Key5816143
MDR Text Key50961476
Report Number2531779-2016-17228
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 07/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age11 MO
Initial Date Manufacturer Received 07/05/2016
Initial Date FDA Received07/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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