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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Moisture Damage (1405)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Lethargy (2560)
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 experienced a hyperglycemic event while on the pump.The reporter stated that the patient had a blood glucose of 500 mg/dl with symptoms of extreme drowsiness and nausea.The patient did not receive any treatment above and beyond the normal course of diabetes management.The reporter stated that the pump had lost power.Upon inspection of the pump, moisture corrosion was found in the battery compartment.This complaint is being reported due to the allegation that the pump losing power unexpectedly caused the blood glucose excursion.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 03-dec-2018 with the following findings: during investigation, due to rebooting all required test steps could not be completed.There was moisture entered through battery compartment crack above grip pad.The pump booted to the verified screen and went into a continuous reboot and power loss due to moisture corrosion in the battery compartment.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7735340
• Report Number: 2531779-2018-13757
• Device Sequence Number: 13654617
• Product Code: OYC
• UDI-Device Identifier: 10840406100198
• UDI-Public: 10840406100198
• 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,Followup
• Report Date (Section B): 07/17/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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: 19 YR
• Patient Weight: 70