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The initial reporter received questionable nh3l gen.2 results for seven patients from a cobas 8000 c 702 module, serial number (b)(4).The initial ammonia results for patient¿s 1-5 were reported outside the laboratory, and the initial results for patient¿s 6-7 were not reported outside the laboratory.Refer to the attachment on the medwatch for all initial and repeat ammonia results for patient¿s 1-7.On (b)(6) 2020, the customer recovered high ammonia results on patient 5¿s initial and redrawn sample.Patient 5 was transferred to another facility and the patient was retested using an unknown method.The ammonia result from the other facility was within normal range, 11 umol/l.On (b)(6) 2020, the customer performed repeat testing on patient 5¿s samples as well as quality control.Patient 5¿s ammonia results matched the previous results and quality control was acceptable.The customer noticed that all patient ammonia results from (b)(6) 2020 recovered high.The customer performed repeat testing on these samples, but the results recovered higher due to the sample stability.Next, the customer performed repeat testing on four proficiency samples received in (b)(6) 2019 and (b)(6) 2020.The proficiency sample results were reproducible and were within the target range.Two new patient specimens, patient 6 and patient 7, arrived within the customer¿s laboratory and the initial ammonia results were high.The customer placed a new ammonia reagent onboard the analyzer, lot 416289 serial number (b)(4), and quality control was acceptable.The customer retested patient 6¿s specimen on the new reagent pack and the ammonia recovered within normal range.The customer retested patient's 1-7 with the new reagent pack and the ammonia results recovered lower.The customer determined the ammonia results from the new reagent pack to be correct.The customer reported these results outside the laboratory.Patient 2 is a (b)(6) female with a date of birth of (b)(6).Patient 3 is a (b)(6) male with a date of birth of (b)(6).Patient 4 is a (b)(6) female with a date of birth of (b)(6).Patient 5 is an (b)(6) male with a date of birth of (b)(6).Patient 6 is a (b)(6) male with a date of birth of (b)(6).Patient 7 is a (b)(6) male with a date of birth of (b)(6).
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The customer's calibration and qc were acceptable before patient testing.Based on the customer's precision test results, the field service engineer (fse) discovered the sample pipetting and the cuvette mixing was not optimal.The fse performed preventative maintenance on the analyzer.Based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.
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