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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Structural Problem (2506)
Health Effect - Clinical Codes	Chest Pain (1776); Hyperglycemia (1905); Nausea (1970)
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.(b)(4).
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas and alleged that the patient experienced an elevated blood glucose (bg) of 385 mg/dl with chest pain, nausea and excessive urination associated with an alleged power and damage issue with the pump.Reportedly, the pump was resumed after replacement and the patient did not receive any treatment above and beyond the usual routine of diabetes care and management.During troubleshooting with customer technical support (cts), it was revealed that the battery compartment had stripped threads, the patient was unable to tighten the battery cap onto the pump and there was intermittent power in the pump.It was reported that the pump was rebooting throughout the middle of the night.The patient was advised to use alternate plan of insulin delivery as prescribed by their healthcare provider until a new pump arrives.This complaint is being reported based on the allegation that the patient experienced hyperglycemia because of an intermittent power and damage issue with the pump.
Additional Manufacturer Narrative
Date of submission 25-jun-2018.The device has been returned and evaluated by product analysis on 15-jun-2018 with the following findings: the pump's black box showed that there were unexplained pump reboot events in the black box.The battery compartment was found to be cracked with stripped threads.A test battery cap was able to secure to the pump the pump was exercised for 24 hours with no power issues observed.The pump passed a delivery accuracy test and was found to be delivering within range.The total daily doses added up correctly and reflected the user's programmed basal rates.

• 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: 7265010
• Report Number: 2531779-2018-03250
• Device Sequence Number: 19091752
• Product Code: OYC
• UDI-Device Identifier: 10840406100372
• UDI-Public: 10840406100372
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 01/29/2018

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?: 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: 06/05/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 06/25/2018
• 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
• Patient Age: 16 YR
• Patient Weight: 136