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	Malfunction
Additional Manufacturer Narrative
(b)(4).
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 399 mg/dl with symptoms of confusion and dizziness.The patient did not receive any treatment above and beyond the normal course of diabetes management.The reporter stated that the pump lost power overnight while the patient was sleeping, causing the blood glucose excursion.The reporter noted that there was moisture present in the pump.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event due to the pump losing power.
Additional Manufacturer Narrative
Date of submission (b)(6)-2018 - device evaluation: the pump has been returned and evaluated by product analysis on (b)(6)-2018 with the following findings: a review of the black box showed a call service 064 alarm occurred on the date of the alleged adverse event.Power on reset events were recorded from the user clearing the motor alarms.The pump was returned with moisture behind the display lens, and corrosion in the battery compartment.The battery compartment was cracked on the side from the threads to the cover.A leak was found in the battery compartment crack.The battery cap was not returned.The test battery cap was able to attach to the pump and power it on.The pump emitted a call service 078 alarm during the rewind step.The total daily doses added up correctly.The pump cover was removed to find internal moisture on the motor connector and printed circuit board.The alleged power issue was not duplicated during testing.

• 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: 7681236
• Report Number: 2531779-2018-12811
• Device Sequence Number: 13841266
• Product Code: OYC
• UDI-Device Identifier: 10840406100075
• UDI-Public: 10840406100075
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 06/25/2018

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: 07/31/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 38 MO
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 06/25/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/13/2018; 08/22/2018
• 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: 44 YR
• Patient Weight: 229