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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Chest Pain (1776); Hyperglycemia (1905); Polydipsia (2604)
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.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that a patient had been hospitalized on (b)(6) 2018.The reporter stated that the patient had a blood glucose over 600 mg/dl with symptoms of thirst and chest pains.The patient was treated at the hospital with insulin via injection and intravenous fluids.The patient was on heart disease medications at the time as well.The reporter stated that the pump¿s time and date settings would reset whenever the pump was rebooted.If the patient did not verify the correct time and date when the pump was powered on, the pump would deliver a different basal rate than what the patient would expect.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event as a result of use error of the device.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8068752
• Report Number: 2531779-2018-19649
• Device Sequence Number: 1439502
• Product Code: OYC
• UDI-Device Identifier: 10840406100075
• UDI-Public: 10840406100075
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 10/26/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 44 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/14/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR