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 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 (damage with moisture ingress) issue.The reporter alleged the pump was worn while swimming and afterward, the display screen had gone blank and there was water in the battery compartment noted when the battery was removed.The display screen reportedly illuminated for a short time when the battery was replaced in the pump, but then went blank again.The reporter also stated the keypad buttons were unresponsive.The reporter stated there was a crack in 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 31-jan-2019 with the following findings: a review of the black box showed multiple unexplained power on reset events.The battery compartment was cracked from the threads down to the case seal on the side.The returned battery cap was undamaged and able to fit.Evidence of moisture ingress was observed in the battery canister.The battery cap was fastened and then unscrewed a half turn with no reboots occurring.The leak test failed due a battery compartment leak.The pump alarmed with a call service 064 alarm during the load step.The alleged ¿power¿ complaint was unable to be adequately investigated.The pump cover was removed to find further moisture corrosion to the power printed circuit board, and to the motor flex/connector.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8203636
• Report Number: 2531779-2018-20962
• Device Sequence Number: 10829139
• Product Code: OYC
• UDI-Device Identifier: 10840406100211
• UDI-Public: 10840406100211
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 12/26/2018

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: 01/04/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 30 MO
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 164