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

Medical Device Problem Codes	Moisture Damage (1405); Temperature Problem (3022)
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 temperature (temp - moisture ingress w/ dmg) issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.
Additional Manufacturer Narrative
Date of submission (b)(4)2018 device evaluation: the device has been returned and evaluated by product analysis on (b)(4)2018 with the following findings: a review of the black box showed no evidence of a drastic voltage drop.The battery compartment was cracked at the threads on the side.The battery cap was undamaged and able to fit.Evidence of moisture corrosion was observed in the battery canister and on the battery cap.The leak test failed due a battery compartment leak.The ¿ez-prime¿ steps were performed correctly and all current readings were within specifications.No overheating occurred during the investigation.The alleged ¿temperature¿ issue was unable to be duplicated.The pump cover was removed and no further moisture ingress was found to the power printed circuit board or 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: 7673053
• Report Number: 2531779-2018-12583
• Device Sequence Number: 1553810
• Product Code: OYC
• UDI-Device Identifier: 10840406103229
• UDI-Public: 10840406103229
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 07/02/2018

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: 08/10/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 150