Safety Alert for OPTIUM XCEED DIABETES MONITORING SYSTEM - OPTIUM XCEED DIABETES CONTROL SYSTEM - Record no. 80146501194 - ListNo .: 70099-01, 70098-01, 70098-01. Lots: 01K180D, 01K124D, 02K102D, 02K107D, 02K127D, 03K123D, 07K199D, 05K204D, 05K204D, 06K179D, 11K179D, 07K179D, 06K179D, 06K179D, 03K201D, 06K200D, 01K202D, 08K200D, 09K179D, 06K205D, 07K123D, 08K199D, 09K123D, 09K198D E 10K177D.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Field action initiated because of Abbott Diabetes Care's ADC observation of a higher-than-expected rate of monitors exhibiting damage to the liquid crystal display (LCD) when subjected to a standard drop test. This was observed during a qualification of a new part, where part of the design check drop test involves a standard drop test. As a consequence of this observed fault of display damage, the ADC conducted the same test in the production of monitors and the same display damage was observed. However the monitors affected were only those manufactured after January 31, 2007. At the time the production monitors were identified as being affected, all monitors production and distribution were discontinued and an investigation was initiated.