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

Medical Device Problem Code	Inaccurate Delivery (2339)
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 a history/settings (db mgt inaccurate delivery) issue.It was alleged the pump had an inaccurate delivery issue.The reporter was not able to provide further information during the initial complaint.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there was an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 13-nov-2018 with the following findings: the pump was found to be calculating the correct bolus total.The pump simulated a bolus using the patient's programmed settings and it was found to be functioning correctly.Unrelated to the initial allegation, the battery compartment was cracked.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: 7919235
• Report Number: 2531779-2018-17677
• Device Sequence Number: 16659950
• Product Code: OYC
• UDI-Device Identifier: 10840406100259
• UDI-Public: 10840406100259
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/15/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 26 MO
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR