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

Device Problems Image Display Error/Artifact (1304); Moisture Damage (1405); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the pump has been returned and evaluated by product analysis on 09/28/2016 with the following findings: investigation revealed the following: there was visible moisture corrosion in the battery compartment; the battery compartment was cracked in two places; leak testing revealed a battery compartment leak; the display was dim and discolored.Unrelated to these issues, investigation revealed a crack in the pump casing between the corner of the lens and the case seal.Additionally, evaluation revealed the internal clock battery on the pcb had failed.The pump would not retain the user programmed date and time settings upon removal of the primary aa battery.When a new aa battery is inserted the pump displays the default date and time which must be manually confirmed (or reset) by the user in order to proceed.(b)(6).

Event Description

The pump was returned for investigation.Investigation revealed moisture in the battery compartment, damage to the battery compartment, a battery compartment leak, and a dim display screen.This report is made based on results of investigation completed on 09/28/2016.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 6057390
• MDR Text Key: 58510350
• Report Number: 2531779-2016-29743
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 38 MO
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2013
• 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