The investigation found that the customer was using non-approved quality controls and had not performed daily maintenance on the day of the event.Per product labeling, "use of consumables that were not produced by roche, including but not limited to electrodes, calibration and cleaning solutions, qc-material and related accessories, may result in malfunction of the analyzer and may render the warranty null and void." per product labeling, "before performing the first sample of the day, the 9180 electrolyte analyzer needs to undergo a simple cleaning and conditioning procedure that ensures the analyzer will perform properly." the field service engineer found a defective solenoid valve.No other information was provided.The investigation did not identify a product problem.The root cause of the event could not be determined.
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