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

Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter contacted animas on (b)(6) 2018 alleging an intermittent power issue with the pump beginning (b)(6) 2018.The reporter stated the threads in the battery compartment were stripped.The reporter denied any damage to the battery cap and confirmed that the battery cap had never been replaced.There is no indication the alleged product issue caused or contributed to an adverse event.The device was returned to the manufacturer and investigation completed on 27-aug-2018.On investigation, the black box data revealed multiple unexplained power on reset events recorded on (b)(6) 2018.On examination, the battery compartment was found to be cracked and the returned battery cap had stripped threads.With this damaged cap in place on the pump, the alleged intermittent power issue was duplicated as the damaged battery cap was unable to maintain electrical connection.With a test battery cap in place on the pump, the pump powered on normally and was able to complete ez-prime steps without power interruption.There was no damage, defect or contamination of the pump¿s interior components.Unrelated to the original complaint, the display screen was noted to be dim/discolored.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7834237
• Report Number: 2531779-2018-15691
• Device Sequence Number: 1703761
• Product Code: OYC
• UDI-Device Identifier: 10840406100181
• UDI-Public: 10840406100181
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 08/09/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR