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

Device Problem Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Follow-up #1 date of submission 04/12/2016 device evaluation: the pump has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: a visual inspection of the pump showed that the battery compartment was cracked.Evidence of rust/corrosion was found in the battery compartment.The pump failed a leak test at the battery compartment.Unrelated to the complaint, the display was dim and discolored.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.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

Event Description

On 02/04/2016, the reporter contacted animas, alleging a casing/condition (moisture ingress) issue.It was reported that there was moisture in the battery compartment.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: 10516502
• MDR Text Key: 206549723
• Report Number: 2531779-2020-00207
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• 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: 04/01/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• 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