MAUDE Adverse Event Report: ANIMAS CORPORATION 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) 2017, the reporter contacted animas, alleging a power (moisture ingress) issue.It was noted that there was moisture within the battery compartment.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
Device evaluation: the device has been returned and evaluated by product analysis on 06/28/2017 with the following findings: review of the black box data revealed unexplained power on reset events recorded on (b)(6) 2017.On examination, moisture was visible in the battery compartment.Leak testing revealed moisture leakage due to a crack in the battery compartment.The returned battery was intact and without damage and able to fit properly to the pump.The battery cap was fastened and then unscrewed ½ turn leading the pump to reboot.Investigation duplicated the complaint.The battery cap was fastened and the pump was exercised with no further power interruptions occurring.The pump cover was removed for further investigation and did not reveal any damage, defect or contamination of the pump¿s interior components.(b)(4).

• 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: 6642478
• Report Number: 2531779-2017-12465
• Device Sequence Number: 926325
• Product Code: OYC
• UDI-Device Identifier: 10840406100105
• UDI-Public: 0110840406100105
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/20/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 05/20/2017
• Supplement Date Received by Manufacturer: 05/20/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 130