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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 Moisture Damage (1405); Device Stops Intermittently (1599)
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 power (moisture ingress) issue. The user alleged intermittent power issue and reported that there was moisture behind the display. This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission 06/24/2016 device evaluation: the device has been returned and evaluated by product analysis on 06/14/2016 with the following findings: the pump's black box showed pump reboot events associated with a cartridge change on (b)(6) 2016. There were additional pump reboot events relating to expected replace battery alarms on (b)(6) 2016. There was evidence of moisture behind display lens. The battery compartment was found to be cracked. The pump case was cracked in the corner of the display area. The pump was exercised with the returned battery cap for 24 hours with no reboot, loss of power or call service alarms duplicated. The alleged issue could not be duplicated. There was additional evidence of moisture on the internal components of the pump.
 
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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 Key5666330
MDR Text Key45571579
Report Number2531779-2016-10217
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 05/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610008221267703516
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 Age10 MO
Event Location No Information
Date Manufacturer Received05/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2015
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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