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

Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas alleging that there was a line through the display screen.It was reported that the user¿s blood glucose (bg) reading was greater than 250 mg/dl; however, the bg reading did not exceed 500 mg/dl.No symptoms of hyperglycemia were reported.The alleged bg excursion does not meet animas criteria for a serious injury and is therefore not reportable as an adverse event.This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery.
Additional Manufacturer Narrative
The pump has been returned and evaluated by product analysis on 03/11/2017 with the following findings: during investigation, the pump was powered on and the display screen was found to have a colored horizontal green line through the display screen.A test display was installed and the display was fully functional with no colored lines.

• 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: 6344268
• Report Number: 2531779-2017-03876
• Device Sequence Number: 1503329
• Product Code: LZG
• UDI-Device Identifier: 10840406100600
• UDI-Public: 0110840406100600
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2017

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: 02/15/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR