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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
On (b)(6) 2016, the reporter contacted animas alleging that the pump was not delivering insulin accurately. This complaint is being reported based on the allegation against the delivery function of the pump.
 
Manufacturer Narrative
Follow-up #1; date of submission: 10/17/2016. The device has been returned and evaluated by product analysis on 09/26/2016 with the following findings. The pump's black box data from the date of the event had been overwritten due to continued use of the pump. The available daily insulin delivery totals correctly reflected the user's programmed basal rates. The pump passed a delivery accuracy test with no issues observed. The alleged issue could not be duplicated.
 
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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 Key5647848
MDR Text Key45034415
Report Number2531779-2016-09700
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 04/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610008221238145916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age9 MO
Event Location No Information
Date Manufacturer Received04/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2015
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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