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

Device Problems Crack (1135); Poor Quality Image (1408); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the pump has been returned and evaluated by product analysis on 02/25/2016 with the following findings: investigation revealed a cracked battery compartment.The pump¿s cover was removed, intermittent condition was found to the cgm module due to a cold solder connection at the cgm inter-board gold pin.In addition, the display screen was dim and discolored.Unrelated to these issues, investigation revealed a communication issue between the pump and the cgm (continuous glucose monitoring) transmitter.The review of the black box data and the cgm history showed multiple call service alarms (cs215); however no cs215 alarms were duplicated during the actual investigation.A test transmitter was used and paired correctly with the pump.The pump and the test transmitter were tested overnight and no communication issues were duplicated.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.(b)(6).(b)(4).

Event Description

The pump was returned for investigation.Investigation revealed a cracked battery compartment.In addition, the display screen was dim and discolored.The pump's cover was removed, intermittent condition was found to the cgm module due to a cold solder connection at the cgm inter-board gold pin.This report is made based on results of investigation completed on 02/25/2016.

• 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: 5490172
• MDR Text Key: 40203455
• Report Number: 2531779-2016-05521
• 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: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• 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: 02/03/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 36 MO
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2013
• 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