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

Medical Device Problem Code	Pumping Problem (3016)
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 (history/settings issue) issue.The reporter alleged the basal history did not match the active basal program.It was reported that the patient experienced a blood glucose level of above 250 but below 500, without any other symptoms of hyperglycemia.This incident does not meet animas's definition of an adverse event.This issue is being reported because as 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
Date of submission 07-jun-2018 the device has been returned and evaluated by product analysis on 01-jun-2018 with the following findings: the last basal delivery was on (b)(6)2018 @ 06:38 am.The total daily dose added up and reflected the programmed basal rate target.The battery compartment and cap were undamaged and able to fit.The ez-prime steps were performed correctly.The pump reflected 24 units delivered after 24 hours on 1 unit per hour duration test.The product performed and delivered within specifications.Investigators were unable to duplicate the inaccurate delivery complaint.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7495292
• Report Number: 2531779-2018-08626
• Device Sequence Number: 10811662
• Product Code: OYC
• UDI-Device Identifier: 10840406103229
• UDI-Public: 10840406103229
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/07/2018
• 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
• Patient Weight: 175