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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); Failure to Read Input Signal (1581)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 16-feb-2018 with the following findings: during investigation, a visual inspection of the pump revealed no evidence of moisture in the cartridge compartment. No physical damage was observed on the audio bolus button cover. The audio bolus button was unresponsive during testing. The audio bolus button cover was removed and no defect was found. A leak test failed due to a case seal leak. The pump was opened and moisture was found on keypad flex connector. 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.
 
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) 2018, the reporter contacted animas alleging a button/keypad (abb tactile changes w/moisture) issue. It was reported that the audio bolus button was damaged and was under responsive to user presses and there was moisture present in the cartridge compartment. There is no indication that the product issue caused or contributed to an adverse event. This complaint is being reported because the issue has the ability to result in inadvertent or incorrect boluses which may result in over or under delivery.
 
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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 Key7246725
MDR Text Key108303457
Report Number2531779-2018-02877
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 01/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/28/2018
Was Device Evaluated by Manufacturer? Yes
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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