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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 Failure to Prime (1492)
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 (b)(6) 2016, the reporter contacted animas, alleging that there were loss of prime warnings. This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
(b)(4). Follow-up #1: date of submission 03/15/2017. Device evaluation: the device has been returned and evaluated by product analysis on 02/24/2017 with the following findings: review of the black box data revealed loss of prime warnings recorded 24 oct 2016. On testing, the force sensor was found to be within specifications. Loss of prime was not duplicated during investigation. Unrelated to the original complaint, the audio bolus button was inoperable due to the button slug being missing; complete pump testing was not able to be performed due to the inoperable audio bolus button. Additionally, unrelated to the original complaint, the battery compartment was noted to be cracked. This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device. Follow-up #1: date of submission 03/15/2017. Device evaluation: the device has been returned and evaluated by product analysis on 02/24/2017 with the following findings: review of the black box data revealed loss of prime warnings recorded 24 oct 2016. On testing, the force sensor was found to be within specifications. Loss of prime was not duplicated during investigation. Unrelated to the original complaint, the audio bolus button was inoperable due to the button slug being missing; complete pump testing was not able to be performed due to the inoperable audio bolus button. Additionally, unrelated to the original complaint, the battery compartment was noted to be cracked.
 
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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 Key6278268
MDR Text Key65941724
Report Number2531779-2017-02134
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 12/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2017
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 Manufacturer01/29/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/29/2016
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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