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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 Inaccurate Delivery (2339)
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.
 
Event Description
The reporter contacted animas on (b)(6) 2016 alleging the pump demonstrated an issue with inaccurate delivery, that the "base flow blocked after several hours. " animas customer technical support made several attempts to follow up with the reported for more information regarding this alleged issue, but the reporter did not respond to those attempts. There was no reported adverse physical event associated with this complaint. This complaint is being reported because the alleged remained unresolved.
 
Manufacturer Narrative
Follow up #1 submitted: 04/22/2016. Due diligence follow up information revealed that the complaint did not involve an "inaccurate delivery issue" with the pump. The reporter confirmed that the complaint was of a different nature that will be reported on a separate individual report.
 
Manufacturer Narrative
Follow up #2 submitted 04/22/2016. Due diligence follow up revealed that the user alleged random call service alarm 064 or occlusion alarms with infusion set tubing/site. Instructions were followed for insertion of the infusion set. This complaint is being reported because the alleged occlusion issue remained unresolved.
 
Manufacturer Narrative
Follow-up #1: date of submission 05/26/2016. Review of the black box data revealed the last basal delivery was on (b)(6) 2016@6:51pm. Multiple basal delivery interruption caused by power interruptions are observed from (b)(6) 2016@7:49pm. From (b)(6) 2016@2:42pm. The basal program was manually cleared and the pump was running on a 0. 00 unit per hour empty basal program for 16 days from (b)(6) 2016@08:35am. The total daily doses add up correctly and reflect the programmed basal rate target. No battery cap was returned. The battery compartment was undamaged and a test cap is able to fit to maintain electrical connection. "ez-prime" steps were performed; the pump reflected 24 units after 24 hours on 1. 0 unit per hour duration test. No delivery interruptions occurred during the investigation. The product performed within the required specifications. Investigation did not duplicate the "inaccurate delivery" complaint.
 
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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 Key5596480
MDR Text Key43872208
Report Number2531779-2016-08265
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,Followup,Followup
Report Date 03/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2016
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 Manufacturer04/26/2016
Was the Report Sent to FDA? Yes
Device Age10 MO
Event Location No Information
Date Manufacturer Received03/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2015
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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