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

Medical Device Problem Codes	Premature Discharge of Battery (1057); 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 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) 2017, the reporter contacted animas, alleging a power (battery life w/ moisture) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 06/28/2017 with the following findings: a review of the black box showed no evidence of a short battery life.A discharged replace battery warning was found in the black box.Moisture was found in the battery canister, a leak test failed due to a battery compartment leak.The rewind, load, and prime steps were performed successfully.All currents were reading within specifications.The pump cover was removed to find no further moisture ingress or intermittent conditions to the printed circuit board.

• 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: 6635926
• Report Number: 2531779-2017-12262
• Device Sequence Number: 316592
• 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: 06/01/2017
• 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: 06/12/2017
• Supplement Report FDA Received Date: 07/26/2017
• 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