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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 Burn(s) (1757)
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 there was a temperature issue with no physical damage to the pump. The reporter stated that the patient was burned, but that there was no treatment needed. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission 07/05/2016 device evaluation: the device has been returned and evaluated by product analysis on 06/16/2016 with the following findings: there was no activity related to the pi observed in the black box or download history. No damage was found to the battery compartment or cap. No overheating was duplicated during testing. The pump's electrical current draws were found to be within specification.
 
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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 Key5681456
MDR Text Key45976655
Report Number2531779-2016-10455
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 05/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610008221169150316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age5 MO
Event Location No Information
Date Manufacturer Received05/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2015
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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