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

Device Problems Image Display Error/Artifact (1304); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Follow-up # 1 date of submission (b)(6) 2015 ¿ device evaluation: the pump has been returned and evaluated by product analysis on (b)(6) 2015 with the following findings: visual inspection revealed that the display lens was cracked.During testing, the display was found to be discolored.Initial reporter: (b)(6).

Event Description

On (b)(6) 2015, the reporter contacted animas, alleging a display (damaged) issue.The distributor alleged that the display screen was damaged.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: 10521514
• MDR Text Key: 209357551
• Report Number: 2531779-2020-00220
• 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: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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: 03/04/2015
• Was the Report Sent to FDA?: Yes
• Device Age: 25 MO
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2013
• 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