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

Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hyperglycemia (1905); Nausea (1970)
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
The reporter contacted animas on (b)(6) 2018 alleging the patient experienced hyperglycemia while on insulin pump therapy evidenced by blood glucose measuring >600 mg/dl with large urinary ketones, vomiting, nausea and abdominal pain.The patient was reportedly hospitalized and received insulin via the pump and via intravenous insulin drip.The reporter alleged an inaccurate delivery issue with the pump.Troubleshooting of the device by animas customer support revealed that basal delivery totals in total daily dose matched the active basal program total and basal history matches the active basal program settings indicating the pump was delivering accurately per the patient¿s basal program settings.During troubleshooting, animas customer support became aware that the patient was not responding to an alarm in a timely manner and this is a potential cause of the perceived inaccurate delivery issue.This complaint is being reported because the patient experienced serious injury while on insulin pump therapy associated with a training/misuse issue; troubleshooting did not confirm an inaccurate delivery issue with the pump and basal deliveries were recorded as programmed.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8105365
• Report Number: 2531779-2018-20033
• Device Sequence Number: 1900753
• Product Code: OYC
• UDI-Device Identifier: 10840406100372
• UDI-Public: 10840406100372
• 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
• Report Date (Section B): 11/14/2018

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: 29 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/27/2018
• 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: 15 YR
• Patient Weight: 78