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

Medical Device Problem Code	Device Issue (2379)
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) 2017, the reporter contacted animas, alleging a other (unusual issue) issue.It was noted that there was a delay in insulin delivery.This complaint is being reported because the alleged issue could have an impact on insulin delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 13-nov-2017 with the following findings: during investigation, the black box and alarm history showed no activity outside of the normal use.The last basal delivery was on (b)(6) 2017 and the last bolus delivery was on (b)(6) 2017.The user setting review showed delivery speed was set to ¿slow¿.The ez-prime steps were performed correctly.The 10u bolus was correctly delivered and recorded.The pump reflected a 24u after a 24 hr duration test on 1u hr.The original complaint of the delay in insulin delivery was unable to be duplicated.(b)(4).

• 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: 6986631
• Report Number: 2531779-2017-25233
• Device Sequence Number: 13921715
• Product Code: OYC
• UDI-Device Identifier: 10840406100105
• UDI-Public: 0110840406100105
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/05/2017

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 26 MO
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 143