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 have audible alarm sounds when the pump gives an alarm.There is no indication the alleged product issue caused or contributed to an adverse event.No further information was available.Animas customer support made several attempts to contact the report to complete troubleshooting of the alleged issue; however the reporter did not respond to follow-up attempts.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 evaluation: the device has been returned and evaluated by product analysis on 08-oct-2019 with the following findings:during investigation, audible alarms was tested with alarms and warnings with no defects found.Unable to duplicate complaint regarding audible alarm.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; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8627105
• Report Number: 2531779-2019-03226
• Device Sequence Number: 19358645
• Product Code: OYC
• UDI-Device Identifier: 10840406100051
• UDI-Public: 10840406100051
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 05/16/2019

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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 47 MO
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR