MAUDE Adverse Event Report: ANIMAS LLC 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
Event or Problem Description
The reporter contacted animas on (b)(6) 2018 alleging there was moisture in the battery compartment with an intermittent power issue.The reporter denied damage to the battery compartment and battery cap.The device was returned to the manufacturer and investigation completed (b)(6) 2018.On investigation a review of the black box data did not reveal any records of unexplained power on reset events prior to the complaint date.However, multiple unexplained power on reset events were observed in the black box data after the complaint date, on (b)(6) 2018.On examination, the ¿coin slot¿ on the top of the battery cap was noted to be worn; the battery cap was evaluated and found to measure within the required specifications.The battery compartment was noted to be cracked with evidence of moisture contamination inside the battery compartment.The returned battery cap was unable to fully tighten to the pump and an intermittent power issue was duplicated.Leak testing confirmed moisture ingress into the battery compartment at the site of the battery compartment crack.There was no damage, defect or contamination of the interior pump components.The pump was unable to be exercised on a 12-hour basal program for delivery accuracy due to intermittent power interruptions resulting from battery compartment damage and moisture contamination.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7836641
• Report Number: 2531779-2018-15795
• Device Sequence Number: 11062296
• Product Code: OYC
• UDI-Device Identifier: 10840406100228
• UDI-Public: 10840406100228
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 08/10/2018

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: 08/23/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 23 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR