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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Vomiting (2144)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device 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.(b)(4).
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas and alleged the patient experienced on (b)(6)2019 a blood glucose as high as 400mg/dl, with nausea, vomiting, fever, sweating, tachycardia, headache, and symptoms of dehydration, associated with an alleged inaccurate delivery issue.Reportedly, the patient resumed treatment with the same pump, and was treated in the hospital by their healthcare provider with insulin via injection, and intravenous fluids.During troubleshooting with customer technical support, it was revealed the basal delivery totals in total daily dose did not match due to a suspend, an accessed basal edit screen, the customer making changes to the basal program.The customer allegedly made changes to their basal program after the blood glucose excursion.The basal history matched the active basal program settings.The bolus totals matched, and all boluses were recorded as programmed.The patient was referred to their healthcare provider for diabetes management.This complaint is being reported because the alleged blood glucose excursion was related to a training/misuse issue and the patient was referred to their healthcare provider for further diabetes management.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8748129
• Report Number: 2531779-2019-03797
• Device Sequence Number: 2280555
• Product Code: OYC
• UDI-Device Identifier: 10840406103137
• UDI-Public: 10840406103137
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/17/2019

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?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/01/2019
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 130