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

Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Hyperglycemia (1905)
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.
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 507 mg/dl.The patient reportedly did not have a backup plan for insulin delivery.Animas customer support advised the patient to contact their health care provider to obtain a backup plan for treatment of the hyperglycemia.The reporter alleged that the pump had been without power all day on (b)(6) 2018; the display screen was blank and after rebooting the pump with a new battery, there was no power to the pump all day.The reporter denied damage to the pump or the battery cap and denied moisture in the pump.The reporter confirmed that the battery cap could be secured to the pump per the instructions for use.The reporter confirmed the correct battery type was being used in the pump and the power issue occurred immediately after the battery was changed.This complaint is being reported because the patient reportedly experienced serious injury while on insulin pump therapy associated with an issue of no power to the pump.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7863707
• Report Number: 2531779-2018-16412
• Device Sequence Number: 16647423
• Product Code: OYC
• UDI-Device Identifier: 10840406100235
• UDI-Public: 10840406100235
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 08/28/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 27 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/11/2018
• 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: 53 YR