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

Model Number 11451100

Device Problems Electrical /Electronic Property Problem (1198); Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Follow-up #1: date of submission 07/14/2016.Device evaluation: the device has been returned and evaluated by product analysis on 06/23/2016 with the following findings: the review of the black box showed recurring power reboots.Investigators were able to duplicate the intermittent power issue during the battery cap functional test; however, investigators were able to successfully run the pump on a 24-hour basal delivery program with no intermittent power reboots.The returned battery cap was able to tighten to the returned pump and to the test pump.Additionally, investigation revealed evidence of moisture in the battery compartment, underside the returned battery cap, and behind the display lens.A leak test was performed and failed due to a battery compartment leak.The pump was opened up and evidence of moisture was found throughout the internal pump components and on the main printed circuit board.No damages were noted to the power circuit.Unrelated to the original complaint, the battery compartment was noted to be cracked in two places.In addition, the pump casing and the cartridge compartment were observed to be cracked.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.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a power (moisture ingress) issue.The reporter alleged intermittent power issue.In addition, it was reported that there was moisture behind the display.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: jon mulberg ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 10515108
• MDR Text Key: 206353863
• Report Number: 2531779-2020-00205
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11451100
• Device Catalogue Number: 11451100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• 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 Age: 26 YR