The initial reporter complained of questionable results for multiple patients from two cobas 8000 c 702 modules and one cobas 6000 c (501) module.The customer believes that the patient's results are being affected by lipemia in the blood sample.From the data provided: 3 patients had questionable crej2 creatinine jaffé gen.2, trigl triglycerides, and chol2 cholesterol gen.2 results.1 patient had questionable crej2 and trigl results.6 patients had questionable crej2 results.1 patient had questionable hdlc4 hdl-cholesterol plus 4th generation, trigl, and chol2 results.2 patients had questionable trigl results.5 patients had questionable trigl and chol2 results.The date of the event is the earliest known date that a questionable patient result was obtained.The customer indicated that this has been an ongoing issue.This medwatch will cover hdlc4.For crej2, trigl, and chol2 refer to the med watches with patient identifiers (b)(6) respectively.The customer verified that there was no allegation of any adverse events for any patients.The customer did not specify which results were from which analyzers.But they did provide the following instrument serial numbers: cobas c702 (b)(4), cobas c702 (b)(4), and cobas c501 (b)(4).
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