MAUDE Adverse Event Report: ANIMAS CORPORATION 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 device has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging a history/settings (diabetes management inaccurate delivery) issue.The basal delivery totals in total daily dose did not match due to the basal edit screen being accessed, and the customer making changes to the basal program.The basal history matched the active basal program settings.The bolus totals matched and all boluses were recorded as programmed.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 06-dec-2017 with the following findings: during investigation, the black box shows a unexplained loss of prime followed by a por on (b)(6) 2017 at 06:47; insulin deliveries resumed (b)(6) 2017 at 20:05.The last basal delivery was on (b)(6) 2017.The last bolus delivery was a 1.0u normal bolus on (b)(6) 2017 at 20:40.Pump was exercised for 24 hrs with a 2.0 u/hr basal rate; at end testing the basal history correctly showed 2.0 u and tdd showed 48.0 u.The tdd¿s add up correctly and reflect the users programmed basal rates.Pump passed delivery accuracy testing with no delivery defects found.Pump found to be delivering within required range and delivering accurately.No eaw¿s or delivery interruptions occurred during the testing.Unable to duplicate the complaint.Unrelated to the original complaint, battery compartment is cracked above and below the bumper pad.

• 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: 6978874
• Report Number: 2531779-2017-24863
• Device Sequence Number: 648869
• Product Code: OYC
• UDI-Device Identifier: 10840406100037
• UDI-Public: 0110840406100037
• Combination Product (Y/N): N
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2017

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: 10/23/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 12/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 115