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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); Moisture Damage (1405)
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 (moisture ingress) issue. It was reported that there was moisture behind the display and no power in the pump. 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 12/08/2016. Device evaluation: the device has been returned and evaluated by product analysis on 11/09/2016 with the following findings: during the investigation, that pump could not be powered on. The attempt to download the pump history and black box was unsuccessful due to internal moisture damage. The pump failed the 24 hour basal program due to having no power. It was observed that the audible and vibratory alarms were inoperable. During visual inspection of the pump, it was observed that the battery compartment and the returned battery cap were undamaged. The returned battery cap was able to attach securely to the pump. Unrelated to the initial complaint, it was observed that the pump case was cracked between the case seal and the keypad. A leak test was performed and failed due to leaks at the crack in the pump case. It was also observed that there was moisture in the display. The pump was opened and there was moisture damage found on the printed circuit board (pcb). The loss of power issue was duplicated during this investigation.
 
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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 Key6052102
MDR Text Key58497887
Report Number2531779-2016-29556
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 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age8 MO
Event Location No Information
Date Manufacturer Received10/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2016
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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