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 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) 2017, the reporter contacted animas, alleging a power (battery life w/ moisture) issue; moisture behind the display.This complaint is being reported because the issue may result in a long-term cessation of insulin delivery if the user is unable to resolve the alarm.There was no indication that the product caused or contributed to an adverse event.
Additional Manufacturer Narrative
Follow-up #1: date of submission (b)(6) 2017 device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2017 with the following findings: a review of the black box showed an unusual fluctuation of voltage leading to a low battery warning, and the user had installed partially discharged batteries resulting in replace battery alarms.The pump was returned with moisture behind the display lens.A leak was found in the display lens.No moisture/corrosion was found in the battery compartment.The battery cap was not returned.The test battery cap was able to attach to the pump and power it on.The pump current draws were out of specifications.The battery life complaint was duplicated.The pump cover was removed to find moisture ingress on the continuous glucose monitoring module.

• 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: 6714103
• Report Number: 2531779-2017-14862
• Device Sequence Number: 1444911
• Product Code: OYC
• UDI-Device Identifier: 10840406100365
• UDI-Public: 0110840406100365
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/16/2017

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR