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

Medical Device Problem Codes	Moisture Damage (1405); Structural Problem (2506)
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 casing/condition (case damage w/moisture) issue.It was reported that the battery compartment was cracked/damaged, which was noticed after swimming while wearing the pump.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
Follow-up #1: date of submission 10/18/2017 - device evaluation: the pump has been returned and evaluated by product analysis on 09/21/2017 with the following findings: during investigation, the battery compartment was found to be cracked from the threads down to the case seal on the side.Moisture corrosion was observed in the battery canister.Unrelated to the original complaint, further investigation revealed the pump was unable to power on, and moisture corrosion was found on the display screen inside the pump.A leak test was performed and failed due to a battery compartment and bolus button leak.The pumps cover was removed, and further moisture corrosion was found on the cgm module, the display screen, and on the printable 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: 6758077
• Report Number: 2531779-2017-16735
• Device Sequence Number: 16516813
• Product Code: OYC
• UDI-Device Identifier: 10840406100105
• UDI-Public: 0110840406100105
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/07/2017

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: 08/01/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 225