MAUDE Adverse Event Report: ANIMAS LLC 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 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) 2018, the reporter contacted animas, alleging that there was a call service 064 alarm.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.There was no allegation of an adverse event associated with this complaint.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 08-oct-2018 with the following findings: a review of the pump¿s black box and alarm history showed a cs 064 call service.During testing, the pump was powered on to the verify screen with no alarms.The pump rewind, load and prime steps were performed successfully and the pump was exercised for 12 hours with no call service alarms occurring.The complaint of a cs 064 call service alarm issue was not duplicated during investigation.Unrelated to the complaint, the battery compartment was observed to be cracked below the bumper pad.The pump was opened and there was evidence of moisture corrosion on ir and on transceiver boards, and near the motor flex connector.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 LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7746872
• Report Number: 2531779-2018-14132
• Device Sequence Number: 11201771
• Product Code: OYC
• UDI-Device Identifier: 10840406100549
• UDI-Public: 10840406100549
• Combination Product (Y/N): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR