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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 Temperature Problem (3022)
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.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a temperature (temp - no physical damage) issue. There was no reported bodily injury due to the temperature issue. This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.
 
Manufacturer Narrative
Follow-up #1: date of submission 02/01/2017 device evaluation: the device has been returned and evaluated by product analysis on 01/24/2017 with the following findings: a review of the black box showed no evidence of unusual voltage fluctuations. The rewind, load, and prime steps were performed successfully. The battery cap was undamaged and was able to fit securely. All currents read within specification. No overheating occurred during the investigation. The pump cover was removed to find no intermittent conditions to the printed circuit board or the continuous glucose monitoring module. The complaint of a temperature issue was unable to be duplicated. Unrelated to the original complaint the battery compartment was cracked below the grip pad.
 
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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 Key6131924
MDR Text Key61242342
Report Number2531779-2016-32385
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 11/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2016
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 Manufacturer11/30/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age6 MO
Event Location No Information
Date Manufacturer Received11/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
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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