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

Device Problems Electrical /Electronic Property Problem (1198); Structural Problem (2506)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); Palpitations (2467)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to animas.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 Description

On (b)(6) 2018 the patient contacted animas alleging a blood glucose level of 267 mg/dl accompanied by symptoms of chest pain/heaviness and heart palpitations.The patient did not allege any ketone bodies were present, or any medical intervention was required.Reportedly, the patient alleged the pump experienced a loss of prime due to intermittent power issues, along with a cracked battery compartment.The patient alleged the battery cap was unable to be tightened, and the pump would continuously beep and randomly show the verify screen.The patient stated the cap has not been replaced after four to six months.The patient was advised to come off the pump; however, the patient remained on the pump and the basal rate and bolus setting were adjusted.This complaint is being reported because the intermittent power with damage to the pump may have caused or contributed to the alleged hyperglycemic event.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 27-sep-2018 with the following findings: a review of the black box showed the data from the date of the complaint had been overwritten due to continuous use.A review of the daily insulin delivery totals showed the pump was delivering accurately until the last date used by the patient.The total daily doses appeared to be inaccurate due a power interruption reflected in the basal history with zero unit basal program.The battery compartment was cracked from the threads down to the case seal and below the grip pad.The returned battery cap was undamaged and able to fit.The battery cap was fastened and then unscrewed a half turn with no reboots occurring.A delivery accuracy test was performed on the returned pump and was found to be delivering accurately within the required specifications.No insulin delivery or functional defects were found with the returned pump.The pump cover was removed and no intermittent conditions were found to the power printed circuit board.The alleged power issue was unable to be duplicated during investigation.Unrelated to the original complaint, the display screen contrast was dim and reddish.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 7715870
• MDR Text Key: 114887920
• Report Number: 2531779-2018-13335
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10840406100051
• UDI-Public: 10840406100051
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 34 MO
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR
• Patient Weight: 167