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.The reporter alleged moisture was behind the display.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 30-jul-2018 with the following findings: during investigation, there were.Unexplained pump reboots observed in the black box.Battery compartment was cracked above & below the bumper pad.The pump was returned with moisture behind the display lens.There was no damage found to battery compartment or returned battery cap.Returned battery cap fully attaches to the pump and was used to complete a 24hr duration test; no power interruptions were duplicated during this time.A leak test failed due to cover crack on front of pump between lens bezel and case seal.Removed pump cover; internal moisture was observed on the pcb & 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: 7707371
• Report Number: 2531779-2018-13273
• Device Sequence Number: 16495191
• Product Code: OYC
• UDI-Device Identifier: 10840406100266
• UDI-Public: 10840406100266
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 07/07/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Initial Date Received by Manufacturer: 07/07/2018
• Supplement Date Received by Manufacturer: 07/07/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 150