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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
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 button/keypad (tactile changes w/moisture) issue; moisture behind the display and response issues with up arrow, down arrow and ok buttons. This complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
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. Device evaluation: the device has been returned and evaluated by product analysis on 12/10/2016 with the following findings: on investigation, there was moisture behind the display lens. The pump would not power on for testing. Leak testing revealed a leak at the display lens. The keypad was intact and without damage. The keypad cover was removed for investigation and revealed no contamination on the contacts of the keypad buttons. There was moisture throughout the pump interior compartment including the keypad flex connector. Product analysis was unable to test the keypad button response because the pump failed to power on for testing due to the moisture damage.
 
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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 Key6108313
MDR Text Key60383282
Report Number2531779-2016-31485
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 10/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2016
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 Manufacturer12/06/2016
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/22/2016
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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