Mindray Medical issued an urgent field safety notice in Europe to warn of a calibration-related accuracy issue with Cardinal Health’s (NYSE:CAH) Genius 2 tympanic thermometers that are integrated into four versions of the Mindray VS-900 patient monitors.
The affected Genius 2 thermometers were manufactured after Oct. 1, 2016, and may have been distributed with the Mindray VS-900 and N-Series (N12, N15, N17, N19) patient monitors. They also may have been distributed separately as an accessory to the monitors. Affected products have serial numbers greater than N16597907, according to the safety notice.
In November 2019, Cardinal Health issued an urgent field safety notice regarding the issue with the Genius 2 and Genius 3 tympanic thermometers. The reported issue was that the Genius devices’ frequency of calibration as stated in the operating manual may not ensure that the thermometers remain within the stated accuracy range, which is ± 0.2°C for Genius 2 and ± 0.3°C for Genius 3 thermometers.
Cardinal Health said the measurement readings go up over time, meaning the thermometers could exceed the accuracy tolerance of +0.2°C for Genius 2 or +0.3°C for Genius 3, which could result in misdiagnosis and/or delay in treatment. According to Mindray’s notice, the likelihood of harm occurring is low and there have been no reports of serious injury or patient harm.
Mindray said that Cardinal Health updated the manual to require that the thermometers be calibrated at an increased frequency. The items’ genius checker/calibrator will also need a software update to tighten the calibration tolerance limit.
Following calibration, users are urged to contact Cardinal Health to schedule a software update and to calibrate the devices every 25 weeks to ensure that it remains within the stated accuracy range.