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

Medical Device Problem Code	No Audible Alarm (1019)
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
On (b)(6) 2019, the reporter contacted animas alleging the pump did not emit an audio tone when the pump gave a replace battery alarm.The reporter stated the vibratory feature of the pump was operating properly.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because the issue may cause the user to miss an alarm or warning that may cause cessation of insulin delivery.
Additional Manufacturer Narrative
Device analysis: the device was returned to the manufacturer and investigation completed by product analysis on 11-apr-2019 with the following findings: on investigation, the pump¿s auditory tone was fully functional.A replace battery alarm was simulated and the pump gave the appropriate auditory tone alarm.Investigation did not duplicate the complaint.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8386879
• Report Number: 2531779-2019-01685
• Device Sequence Number: 13995966
• Product Code: OYC
• UDI-Device Identifier: 10840406103229
• UDI-Public: 10840406103229
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 03/04/2019

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: 03/13/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 185