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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Moisture Damage (1405)
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) 2018, the reporter contacted animas, alleging a power (moisture ingress) issue.The reporter stated there was no damage to the battery compartment or the battery cap.The yellow o-ring on the battery cap was confirmed to not be visible when the cap is secured to the pump.The reporter stated there was moisture corrosion inside the battery compartment.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 10-jan-2019 with the following findings: a visual inspection of the pump revealed the battery compartment was cracked from the threads to the case seal.There was moisture damage observed in the battery compartment.The returned battery cap was stripped and was unable to secure tightly to power on the pump, duplicating the power issue.A leak test was performed revealing a battery compartment leak.A test battery cap was able to secure enough and power up the pump.The pump was exercised for 12 hours using the test cap with no power interruptions occurring.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.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8032127
• Report Number: 2531779-2018-19054
• Device Sequence Number: 16554876
• Product Code: OYC
• UDI-Device Identifier: 10840406100341
• UDI-Public: 10840406100341
• 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,Followup
• Report Date (Section B): 10/19/2018

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: 01/09/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 25 MO
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 73