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 device has been returned to animas for evaluation.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 in the battery compartment.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
Follow-up #1: device evaluation: the device has been returned and evaluated by product analysis on 23-jul-2018 with the following findings: during investigation, the battery compartment was cracked from the threads down to the case seal on the side and below the grip pad.The returned battery cap was undamaged and able to fit.Evidence of moisture corrosion was observed in the battery canister and on the display screen inside the pump.The leak test failed due a battery compartment leak.The pump was unable to power up and was completely unresponsive.The reported power complaint was duplicated.The pump cover was removed to find further moisture corrosion on the power printed circuit board and to the continuous glucose monitoring module.

• 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: 7698525
• Report Number: 2531779-2018-13061
• Device Sequence Number: 19270876
• Product Code: OYC
• UDI-Device Identifier: 10840406100334
• UDI-Public: 10840406100334
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 06/28/2018

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: 07/12/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR