MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Codes	Moisture Damage (1405); Failure to Read Input Signal (1581); Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2016, the reporter contacted animas, alleging a button/keypad (audio bolus button damage prior to tactile change with moisture) issue.The reporter alleged the audio bolus button was under responsive.The audio bolus button cover was missing/peeling prior to this occurrence.It was also alleged that there was moisture behind the display screen.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because the issue has the ability to result in inadvertent or incorrect boluses which may result in over or under delivery.
Additional Manufacturer Narrative
Follow-up #1: date of submission 10/10/2016 device evaluation: the device has been returned and evaluated by product analysis on 09/16/2016 with the following findings: during investigation, moisture was found behind the display lens.The audio bolus button cover was missing.A leak test was performed and failed due to a leak in the audio bolus button.The pump was unable to be powered on and the display and keypad buttons were unable to be tested.The pump was opened to find evidence of moisture throughout the pump internally.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 5934004
• Report Number: 2531779-2016-24411
• Device Sequence Number: 16248731
• Product Code: LZG
• UDI-Device Identifier: 10840406100570
• UDI-Public: 0110840406100570
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 10/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR