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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 Problems Break (1069); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a temperature (temp - physical damage) issue. It was reported that the battery compartment, battery cap and display lens were damaged. 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
Device evaluation: the device has been returned and evaluated by product analysis on 8/02/2016 with the following findings: a review of the pump¿s black box and download history did not find any activity related to the complaint. The battery compartment and battery cap were intact and the battery cap could be fully tightened onto the pump. The pump powered on normally with no overheating or alarms duplicated during the investigation. The pump¿s ¿ez-prime¿ steps were performed correctly and all of the pump's electrical current draws were found to be within specification. The pump cover was removed and there were no intermittent condition found to the power circuit. The investigation was unable to duplicate the initial ¿temperature¿ complaint. (b)(4).
 
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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 Key5775792
MDR Text Key49648869
Report Number2531779-2016-14999
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 06/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610008221218180216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age10 MO
Event Location No Information
Date Manufacturer Received06/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2015
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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