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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pump 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) 2018, the reporter contacted animas alleging that the patient experienced a low blood glucose associated with an alleged environmental exposure issue.Reportedly, it is unknown if the patient discontinued pump therapy.The patient was treated by emergency medical services.During troubleshooting with customer technical support, it was reported that the patient had an in body, body scan and the health care facility did not tell the patient to take the pump off.After the procedure, the pump kept beeping and the pump gave the patient too much insulin.The pump was not available at the time to troubleshoot.This complaint is being reported because the patient experienced hypoglycemia associated with user error.
Additional Manufacturer Narrative
Follow-up #1: date of submission 28-may-2019 device evaluation: the device has been returned and evaluated by product analysis on 21-may-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 daily insulin delivery totals correctly reflected the user's programmed basal rate until deliveries were halted by the user.The pump passed delivery accuracy testing, and flow accuracy testing, and was found to be delivering within the required specifications.The pump was reported exposed to an x-ray.Unrelated to the original complaint, 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.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

• 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: 7552809
• Report Number: 2531779-2018-09929
• Device Sequence Number: 178982
• Product Code: OYC
• UDI-Device Identifier: 10840406100235
• UDI-Public: 10840406100235
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 05/16/2018

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?: No
• 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: 05/17/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 25 MO
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 05/28/2019
• 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: 24 YR