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

Medical Device Problem Codes	Moisture Damage (1405); Failure to Read Input Signal (1581)
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) 2017, the reporter contacted animas, alleging a button/keypad (audio bolus button tactile changes with moisture) issue.It was reported that moisture was located in the battery compartment and that the audio bolus button was under-responsive, which was noticed after going on a boat while wearing the pump.There was no indication that the product caused or contributed to an adverse event.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.
Additional Manufacturer Narrative
The device has been returned and evaluated by product analysis on 10/23/2017 with the following findings: during investigation, moisture was observed in the battery compartment.The audio bolus button (abb) was found to be responding properly.The abb was removed and no damage or moisture was observed.The original complaint of an abb response issue could not be duplicated.Unrelated to the original complaint, the battery compartment was found to be cracked near the top left corner of the grip pad.A leak test was performed and a leak was identified in the battery compartment.The pump cover was opened and moisture corrosion was observed on the printed circuit board.

• 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: 6869495
• Report Number: 2531779-2017-21432
• Device Sequence Number: 13758369
• Product Code: OYC
• UDI-Device Identifier: 10840406100037
• UDI-Public: 0110840406100037
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/04/2017

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: 10/04/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 180