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

Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to animas.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 and alleged on (b)(6) 2017 the patient experienced a blood glucose of 390mg/dl, with an alleged inaccurate delivery issue.Reportedly, the patient received unspecified treatment in the emergency room by their healthcare provider.During troubleshooting with customer technical support, the patient stated the pump was ¿giving too much insulin¿.This complaint is being reported because the patient received treatment in the emergency room associated with an inaccurate delivery issue.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 28-jan-2019 with the following findings: a review of the black box showed the data from the date of the complaint had been overwritten due to continuous use.The available pump history showed no evidence of a pump delivery malfunction.The pump passed all delivery accuracy testing.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 CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6992469
• Report Number: 2531779-2017-25515
• Device Sequence Number: 1496370
• Product Code: OYC
• UDI-Device Identifier: 10840406100020
• UDI-Public: 0110840406100020
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 01/21/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 45 YR