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); Vomiting (2144)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pump has been returned to animas and investigated on 20-aug-2018 with the following findings: a review of the pump history determined that the patient changed their basal program on 04-aug-2018.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that a patient had experienced a hyperglycemic event while on the pump.The reporter stated that the patient had a blood glucose of 400 mg/dl with symptoms of dehydration, nausea, and vomiting.The patient did not receive any treatment above and beyond the normal course of diabetes management.The reporter stated that the pump was not delivering accurately.A review of the pump history showed that the basal deliveries did not match the active basal rates.The pump was returned to animas and investigated.The investigation of the device determined that the pump¿s basal program was manually changed by the patient on the date of the event.This complaint is being reported due to the patient experiencing 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: 7800713
• Report Number: 2531779-2018-15179
• Device Sequence Number: 19419868
• Product Code: OYC
• UDI-Device Identifier: 10840406100372
• UDI-Public: 10840406100372
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 08/04/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 28 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2018
• Initial Report FDA Received Date: 08/21/2018
• 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: 17 YR
• Patient Weight: 60