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

Medical Device Problem Codes	Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)
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 call service alarm (call service alarm issue) 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 a long term cessation of insulin delivery if the user is unable to resolve the alarm.
Additional Manufacturer Narrative
Follow-up #1: date of submission 22-dec-2017 - device evaluation: the device has been returned and evaluated by product analysis on 29-nov-2017 with the following findings: during investigation, a ¿cs069¿ alarm was reproduced on power up.The pump was unable to recover from the ¿cs069¿ after reboot.The ¿cs069¿ failure was defined as a language file corruption while retrieving the language text.The ¿cs069¿ failure was written as a ¿cs087¿ failure in the black box.The error was resident to the flash chip (u39).Unrelated to the original complaint, the battery compartment was found to be cracked.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 CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6962887
• Report Number: 2531779-2017-24217
• Device Sequence Number: 1209529
• Product Code: OYC
• UDI-Device Identifier: 10840406100013
• UDI-Public: 0110840406100013
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/30/2017

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: 10/16/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 31 MO
• Initial Date Received by Manufacturer: 09/30/2017
• Supplement Date Received by Manufacturer: 09/30/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 157