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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Moisture Damage (1405)
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) 2018, the reporter contacted animas, alleging a power (moisture ingress) issue.It was noted that there was moisture behind the display.There was no allegation of an adverse event associated with this complaint.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Follow-up #1: date of submission 24-jul-2018 device evaluation: the device has been returned and evaluated by product analysis on 09-jul-2018 with the following findings: during investigation, moisture was found behind the display lens.No damage was found to the returned battery cap.Unrelated to the original complaint, the battery compartment was cracked below the bumper pad.No moisture/corrosion was observed in the battery compartment.The returned battery cap fully attached to the pump.The pump had vibratory and auditory alarms with a blank display screen.A leak test failed due to a battery compartment leak.The pump cover was removed to find moisture ingress on the printed circuit board and internal components.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7645078
• Report Number: 2531779-2018-11916
• Device Sequence Number: 13490809
• Product Code: OYC
• UDI-Device Identifier: 10840406100334
• UDI-Public: 10840406100334
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2018

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: 07/05/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Initial Date Received by Manufacturer: 06/17/2018
• Supplement Date Received by Manufacturer: 06/17/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR