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

Device Problems Structural Problem (2506); Wireless Communication Problem (3283)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Manufacturer Narrative

The pump has been returned and evaluated by product analysis on (b)(6)2016 with the following findings: evaluation revealed cgm history shows ¿no antenna¿ warning on (b)(6)2016.¿ant¿ warning is defined as pump/transmitter communication interruption.The test transmitter was paired with the pump correctly.Bg calibration of 120 mg/dl was accepted in both attempts within 2 hours.The pump and transmitter ran over night with a steady reading of 115 mg/dl within +/- 20%.No¿ant¿ icon or any eaw occurred during the investigation, unable to duplicate ¿ant¿ complaint.The pump¿s cover was removed; no intermittent condition was found to the cgm module or to the pcb.The battery compartment is cracked below the grip pad.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).

Event Description

The pump was returned for investigation.Evaluation revealed cracked battery compartment.This report is made based on results of investigation completed on (b)(6) 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: 6278174
• MDR Text Key: 65943121
• Report Number: 2531779-2017-02053
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100051
• UDI-Public: 0110840406100051
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• 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: 12/04/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 31 YR