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

Medical Device Problem Codes	Image Display Error/Artifact (1304); 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
Device evaluation: the device has been returned and evaluated by product analysis on 12-nov-2018.With the following findings: during investigation, all the keys were responsive to user presses.The keypad cover was removed and there was contamination found under all the key contacts.The display was found to be dim and discolored.The battery compartment was found to be cracked.The battery compartment was found to be leaking and there was evidence of moisture corrosion in the battery compartment.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.(b)(6).
Event or Problem Description
The pump was returned for investigation.Investigation revealed contamination under the keypad buttons, a battery compartment crack, a dim/faded display, and moisture within the pump.This report is made based on results of investigation completed on 12-nov-2018.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8123574
• Report Number: 2531779-2018-20232
• Device Sequence Number: 16577455
• Product Code: OYC
• UDI-Device Identifier: 10840406100044
• UDI-Public: 10840406100044
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 45 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR