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The field application specialist (fas) was at the customer site on (b)(4) 2018 where all the electrodes were replaced as part of monthly maintenance on the cobas 8000 cobas ise module.The fas stated one of the ise channels for sodium (na) was bad.The ise check would not pass for ise indirect na for gen.2 using electrode lot number g72 with expiration date 23-feb-2019.There were no problems with k or cl.The fas ran the ise check again and it still failed.Afterwards, all the electrodes were removed and all connections were dried and confirmed that all o-rings were in place.No liquid was observed in the bottom of the compartment.The cables were plugged into the electrodes securely.The instrument was primed x20 and the ise check was run again.The check still failed.The electrodes were checked again and an attempt was made to calibrated.An error was received during calibration.An additional ise check failed again.The fas replaced the reference electrode and the na electrode with same lot number of g72.The instrument was primed and three additional ise checks failed.The customer does not have any other na electrode lot number.Lot number g72 was delivered on (b)(6) 2018.The fas reinstalled the na electrode that was on the instrument prior to the maintenance that was performed.The lot number for this na electrode is f11.The instrument was primed and the ise check was now successful.The fas reinstalled na electrode with lot g72 and primed the instrument and the ise check failed.The other na electrode with lot f11 was put back on the instrument, primed and the ise check was successful again.The customer received a new na electrode on (b)(6) 2018 but had not installed it yet.After midnight night of (b)(6) 2018 the tech noticed that patient results for na were running low.Ten samples were pulled for comparison testing on both instrument lines of the ise module.The customer was not able to repeat the samples on the other line of the ise module as it was down.The customer repeated the 10 patient samples on the available line of the ise module.The customer was not sure which line the original results were run on.Of the data provided for 6 patient samples, the na results for 3 patient samples were discrepant.Patient 1 initial na result was 144 mmol/l.The repeat result was 150 mmol/l patient 2 (female with date of birth of (b)(6)) initial na result was 139 mmol/l.The repeat result was 146 mmol/l.Patient 3 (male with date of birth of (b)(6)) initial na result was 141 mmol/l.The repeat result was 148 mmol/l.The initial results had been reported outside of the laboratory.The customer does not know which results are correct.Corrected reports were issued with the results from the repeat tests.The customer repeated the patient samples again on the same line as the first set of repeat tests and the results were lower again.They were similar to the initial results.The actual results from this repeat testing were not provided.No additional corrected reports were issued.No adverse event occurred.The ise module serial number was (b)(4).On 03-apr-2018 the field service engineer (fse) installed the new na electrode with a different lot number on a different channel of the instrument than had failed initially.The customer stated they were not having any issues.The customer did not know if the new na electrode was installed on the channel of the instrument that had failed initially.The fse visited the customer site on (b)(6) 2018 and no issues were identified.The internal standard and diluent dispense function was checked.A 40 cup precision was performed.The customer's qc results were a little higher than on the day of the event but they were close to the mean.The instrument calibrated successfully, qcs were within range and the precision check passed.The customer stated they were not having any further issues since the service visit.
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