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

Medical Device Problem Code	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.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a casing/condition (moisture ingress) issue.It was reported that moisture was located 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 alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 28-jun-2018 with the following findings: during investigation, the battery compartment was cracked in the thread area.No evidence of moisture contamination was found inside the battery compartment.A leak test showed a leak at the battery compartment crack.The pump case was removed to find no evidence of moisture contamination inside the pump.

• 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: 7642211
• Report Number: 2531779-2018-11783
• Device Sequence Number: 11217166
• Product Code: OYC
• UDI-Device Identifier: 10840406103229
• UDI-Public: 10840406103229
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2018

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Initial Date Received by Manufacturer: 06/09/2018
• Supplement Date Received by Manufacturer: 06/09/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 125