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 device has not been returned to animas.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 that the time and date reset when the battery was removed from the pump for less than 12 hours.There was no indication that the product caused or contributed to an adverse event.This complaint is being ruled out based on the following: this issue is not likely to cause an adverse event because the pump displays the verify screen after it is rebooted and the time and date must be set to confirm the verify screen.
Additional Manufacturer Narrative
Follow-up #1: date of submission 18-sep-2018.Device evaluation: the device has been returned and evaluated by product analysis on 05-sep-2018 with the following findings: during investigation, the time /date reset to default allegation was duplicated during investigation due to a component failure.The investigation confirmed the non-reportable time/date reset allegation.

• 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: 7667006
• Report Number: 2531779-2018-12399
• Device Sequence Number: 13713163
• Product Code: OYC
• UDI-Device Identifier: 10840406100235
• UDI-Public: 10840406100235
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 06/27/2018

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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR