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 device 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
The reporter contacted animas on (b)(6) 2018 alleging a call service 064 alarm issue.There is no indication the alleged product issue caused or contributed to an adverse event.Troubleshooting could not be completed at the time the complaint was received.Animas customer support made several attempts to contact the reporter to complete troubleshooting; however, the reporter did not respond.There is no indication the alleged product issue 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
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.Device evaluation: the device has been returned and evaluated by product analysis on 01-jul-2019 with the following findings: review of the black box and alarm history did not reveal any records of call service alarm 064; due to continued use of the pump after the alleged call service alarm issue occurred, the pump history from the date of the alleged alarm had been overwritten.On investigation, the pump powered on normally and was exercised for 12 hours without the occurrence of any call service alarms.Investigation did not duplicate the complaint.Unrelated to the original complaint, the battery compartment was noted to be cracked during the investigation.Call service 064 alarm did not observe in the black box and alarm history.Pump information from date of pi has been overwritten.Pump powers on properly with no alarms.Rewind, load and prime steps performed successfully.Battery compartment cracked below and above grip pad.

• 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: 7759035
• Report Number: 2531779-2018-14328
• Device Sequence Number: 11077274
• Product Code: OYC
• UDI-Device Identifier: 10840406100297
• UDI-Public: 10840406100297
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 07/21/2018

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: 06/28/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Initial Date Received by Manufacturer: 07/21/2018
• Supplement Date Received by Manufacturer: 07/21/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 07/03/2019
• 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
• Patient Weight: 58