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

Medical Device Problem Code	No Display/Image (1183)
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 a display (blank screen) issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in an inability to use the product which may lead to long term cessation of delivery.
Additional Manufacturer Narrative
Follow-up #1: date of submission 10/03/2017.Device evaluation: the device has been returned and evaluated by product analysis on 09/08/2017 with the following findings: during investigation, the pump was powered on and the display was found to be blank.The pump cover was opened and the oled was found to be cracked.A test display screen was installed and found to be functioning properly.Unrelated to the original complaint, the battery compartment was found to be cracked from the case seal traveling to the grip pad.

• 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: 6736655
• Report Number: 2531779-2017-15607
• Device Sequence Number: 13764896
• Product Code: OYC
• UDI-Device Identifier: 10840406100327
• UDI-Public: 0110840406100327
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/08/2017

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 the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Initial Date Received by Manufacturer: 07/08/2017
• Supplement Date Received by Manufacturer: 07/08/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 56