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

Medical Device Problem Code	Date/Time-Related Software Problem (2582)
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) 2019, the reporter contacted animas, alleging a history/settings (time/date issue) issue.The reporter alleged that the pump will change from 12 hour mode to 24 hour mode without user intervention.The reporter also alleged that the time and the date on the pump is changing on it's own without user intervention.The reporter confirmed that the time and date is being maintained properly when the battery is removed from the pump for less than 12 hours, indicating the issue is not related to the time and date resetting to the factory default setting.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because a time change during use, without user intervention, may result in the user running the incorrect basal segment leading to over or under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 08-jul-2019 with the following findings: during investigation, the dates in total daily dose history are in congruent changing from (b)(6)2019 to (b)(6)2023, from (b)(6)2023 to (b)(6)2019, and from (b)(6)2019 to (b)(6)2019.There was no data in black box from these dates due to continued use.A timekeeping accuracy test was performed; the pump was keeping time accurately.Unrelated to the original complaint, the pump powered on to a dim and discolored display.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: 8473487
• Report Number: 2531779-2019-02310
• Device Sequence Number: 13856160
• Product Code: OYC
• UDI-Device Identifier: 10840406100273
• UDI-Public: 10840406100273
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• 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): 03/29/2019

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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 33 MO
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR