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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 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 a temperature (temp - no physical damage) 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. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission 06/23/2016. Device evaluation: the device has been returned and evaluated by product analysis on 06/10/2016 with the following findings: product evaluation was conducted and the alleged complaint could not be verified or duplicated. The review of the black box data did not show any temperature related activity in the pump history. No damages were observed to the battery compartment or the cap. Additionally, no overheating was duplicated during the actual pump testing. The pump electrical current draws measured within specification. The pump case was opened up and no damages or any evidence of internal moisture were observed. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
 
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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 Key5653737
MDR Text Key45154066
Report Number2531779-2016-09950
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 04/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610005121608852116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age7 MO
Event Location No Information
Date Manufacturer Received04/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2015
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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