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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); 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 device was returned to the manufacturer and investigation completed 11-sep-2018.On investigation, the battery compartment and battery were both intact and without damage.The battery cap was able to fit properly to the pump.Evidence of moisture corrosion was observed on the display screen inside the pump.Leak testing revealed moisture ingress due to a leak in a crack in the pump base.The pump was unable to power on due to internal moisture damage affecting the power printed circuit board, the display screen and the keypad flex/connector.Investigation duplicated the complaint.
Event or Problem Description
The reporter contacted animas (b)(6) 2018 alleging the pump was worn while swimming when the replace battery message appeared and a new battery was installed in the pump.After the battery change, the pump allegedly would not power on and moisture was noted inside the battery compartment.There is no indication the alleged product issue caused or contributed to an adverse event.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7872224
• Report Number: 2531779-2018-16686
• Device Sequence Number: 1567459
• Product Code: OYC
• UDI-Device Identifier: 10840406100273
• UDI-Public: 10840406100273
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 08/23/2018

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: 09/04/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 26 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 183