Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White

FDA device recall Z-1036-2012 · posted 2012-02-15 · Terminated

Recall details

Recalling firm

Viterion TeleHealthcare Llc

Reason for recall

Software defect; Specifically, blood glucose (BG) results from the Roche Aviva meter that are tagged by the user with either the meter hypoglycemic or general "asterisk" flags (*) will not be automatically transmitted through the Viterion 100-BGM monitor containing software version 3.2.0 or displayed to the health care provider through the data server.

Action taken

On May 12, 2011, Bayer Healthcare (aka Viterion) telephoned their consignees regarding the issue with the Viterion 100-BGM and Roche ACCU-CHEK Aviva Flagged Data and followed-up with a letter (dated May 27, 2011) via e-mail. The letter notified customers of the issues and provided information on how to work around the problems. The letter provided the following recommendations: (1) The information concerning the general asterisk (*) flag be communicated within their organization as an amendment to the current patient Safety Alert Notice that was distributed and posted in April 2011. (2) For patients who need to use the Aviva Hypo and/or the asterisk flag, please assign Manual Data Entry for blood glucose on the V100-BGM. The letter informs customers that Bayer has completed the software development to rectify the aforementioned data transmission issue and will upgrade all affected products. Bayer request that customers confirm their receipt of this memo in writing and for any questions concerning this situation, contact Thuy Nguyen, Manager Quality Assurance and Regulatory Affairs at 914-333-6821.

Root cause

Software design

Status

Terminated

Product code

MWI

Quantity affected

3905 units domestically

Distribution

(USA) Nationwide Distribution

Date initiated

2011-05-25

Date posted

2012-02-15

Date terminated

2018-07-02

Location

Tarrytown, NY