​Roche—Potassium and Chloride Electrode Cartridges: Incorrect Seating May Cause Alarms

November 11, 2020 | Risk Management News

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​​ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In an October 29, 2020, Customer Bulletin letter submitted by an ECRI member hospital, Roche states that it has received customer complaints of ISE problems after electrode replacement on the cobas c 311, cobas c 501, and cobas pro ISE analyzers. A problem may occur when the electrodes cannot be seated correctly, causing alarms during ISE check or calibration, most commonly Noise (ISE.N); Electromotive Force (EMF) readings near 323; or low potassium recovery of the high-level urine control from a third-party manufacturer. Roche also states that investigations determined that manufacturing changes to the outside casing of the potassium and chloride electrodes required additional modification; these additional changes have been made. The cobas 8000 ISE module is not affected. Roche further states that no patient or diagnostic test results are affected by this problem. Roche states that medical risk to patients and users can be excluded. This problem is detectable by ISE alarms (ISE.N, ISE.E, and/or IStd. E) on ISE Check and calibration or by out of range QC. The ISE problems may have a variety of causes unrelated to the manufacturing changes. The manufacturer has not confirmed...

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