The customer provided additional information.Date of event was (b)(6) 2014.There were no adverse events.The customer has stated the initial crep result was 112 umol/l, not 113 umol/l.Clarification has been requested but not provided.The customer has stated the repeat crep result was 84 umol/l, not 80 umol/l, and the result of 84 umol/l was reported outside the laboratory.Clarification has been requested but not provided.The customer also stated the patient's sample was repeated twice and another sample was tested and the result of 84 umol/l was confirmed.The crep r1 reagent lot number was 687257-01.The crep r2 reagent lot number was 684128-01.The field service representative went on site.At that time, the customer stated they were having issues with "creatinine fliers" but did not provide any information about patient samples involved.The field service representative adjusted wash levels, replaced the r1 reagent probe, and checked the gear pump pressure.There have been no further complaints from the customer.A specific root cause could not be determined with the information provided.Additional details for further investigation were requested but not provided.
|
The customer alleged they received a questionable creatinine plus (crep) result for one patient.The customer stated they repeated approximately 30 samples from the day's workload, including 4 samples run in and around the same time as the affected sample, and all the repeat results were similar to the original results.The analyzer this event occurred on was requested but not provided.The specific date of this event was requested but not provided.The patient's initial crep result was 113 umol/l and it was reported outside the laboratory.The client questioned the result and the sample was repeated.The repeat result was 80 umol/l.Information on whether the patient was adversely affected was requested but not provided.The crep reagent lot number and expiration date were requested but not provided.
|