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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 31-jul-2018 with the following findings: during the investigation, multiple unexplained power resets were observed in the black box.The battery cap was not returned with the pump.A test battery cap was able to fit to maintain electrical connection and was used to complete a 24-hour duration test with no power resets being duplicated during that time.Unrelated to the original complaint, a battery compartment crack was observed.Corrosion was also observed inside the battery compartment.A leak test failed with a battery compartment leak.The pump¿s cover was removed, and no further evidence of moisture was observed on the printed circuit board or the pump¿s internal components.No damage to the power circuit was found.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a power (intermittent power) issue.There was no indication that the product 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.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7746450
• Report Number: 2531779-2018-14121
• Device Sequence Number: 1280181
• Product Code: OYC
• UDI-Device Identifier: 10840406100358
• UDI-Public: 10840406100358
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 07/12/2018

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: 07/18/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 24 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR