MAUDE Adverse Event Report: ANIMAS CORPORATION 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) 2017, the reporter contacted animas, alleging a history/settings (time loss/gain) issue.It was alleged that the pump was off by five minutes per month.There was no indication that the product caused or contributed to an adverse event.This issue is being reported time loss or gain during use, without user intervention, may result in the user running the incorrect basal segment leading to over or under delivery.
Additional Manufacturer Narrative
The device has been returned and evaluated by product analysis on 17-jan-2018 with the following findings: a review of the black box showed no unexplained time loss/gain issues.Several manual time and date changes were found in the black box.The pump passed time keeping accuracy testing.The pump was able to maintain the time and date settings with accuracy, and no hypersensitive or stuck keys were found on the keypad.The time loss/gain issue was not duplicated during investigation.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7168121
• Report Number: 2531779-2018-00349
• Device Sequence Number: 19266648
• Product Code: OYC
• UDI-Device Identifier: 10840406100297
• UDI-Public: 10840406100297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/01/2018
• 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