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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 Electrical /Electronic Property Problem (1198); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
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 power (damage) issue.It was alleged that the battery compartment was cracked.There was no allegation of an adverse event associated with this complaint.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
 
Manufacturer Narrative
Follow-up #1: date of submission 03/10/2017 device evaluation: the device has been returned and evaluated by product analysis on 02/16/2017 with the following findings: a review of the black box showed one power on reset event.The battery compartment was cracked at the threads to the left side of the grip pad down to the seal.The threads on the battery cap were stripped and were unable to fit.A test cap was able to fit.The test cap was tightened and unscrewed a half turn leading the pump to reboot and duplicate the power complaint.The test cap was fastened and no further loss of power issues occurred during the ez-prime or 24 duration testing.Unrelated to the original complaint, the cartridge compartment was cracked.(b)(4).
 
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Brand Name
ANIMAS VIBE
Type of Device
INSULIN 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 Key6245960
MDR Text Key65030642
Report Number2531779-2017-01030
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10840406100051
UDI-Public0110840406100051
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 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age16 MO
Date Manufacturer Received12/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age61 YR
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