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

Medical Device Problem Code	Low Audible Alarm (1016)
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) 2019, the reporter contacted animas, alleging a audio tone/vibration (quiet sounds) issue.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 evaluation: the device has been returned and evaluated by product analysis on 27-aug-2019 with the following findings: during testing, the pump was powered on and the audible sound feature was found to be above the acceptable limit.The vibratory feature was also functioning normally.The complaint of a quiet sounds issue was not duplicated during investigation.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: 8738896
• Report Number: 2531779-2019-03766
• Device Sequence Number: 1490085
• Product Code: OYC
• UDI-Device Identifier: 10840406103137
• UDI-Public: 10840406103137
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 06/25/2019

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: 08/26/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 150