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

Model Number 13920000

Device Problems Premature Discharge of Battery (1057); Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

On (b)(6) 2020, the reporter contacted animas alleging a power (battery life w/ moisture) issue.It was noted that there was moisture behind the display after swimming with the pump.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in a long-term cessation of insulin delivery if the user is unable to resolve the alarm.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 26-feb-2020 with the following findings:.During investigation, there were frequent low battery warnings observed in alarm history.The pump electrical current draws tested within specifications.The pump case is cracked near top right corner of display.The pump leaks at crack in case.Pump opened; moisture damage found on the printed circuit board.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; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: kristen lopolito ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 9699458
• MDR Text Key: 178765264
• Report Number: 2531779-2020-00074
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10840406103137
• UDI-Public: 10840406103137
• 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,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 13920000
• Device Catalogue Number: 13920000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: Yes
• Device Age: 26 MO
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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: 65 YR
• Patient Weight: 190