Catalog Number 05168589190 |
Device Problems
Low Test Results (2458); Non Reproducible Results (4029)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/06/2023 |
Event Type
malfunction
|
Event Description
|
The initial reporter complained of a discrepant low result for 1 patient urine sample tested for crep2 creatinine plus ver.2 (crep2) on a cobas 8000 c 702 module.The initial result from the c702 module was 155.58 mg/dl.The same sample was also sent to another laboratory where the result was 306.21 mg/dl.The initial result from the c702 module was reported outside of the laboratory where it was questioned by the nurse.The customer repeated the sample twice on the c702 module with results of approximately 300 mg/dl.An aliquot from the sample sent to the other laboratory was also repeated twice with results of approximately 300 mg/dl.The result of 306.21 mg/dl and the repeat results of approximately 300 mg/dl were believed to be correct.
|
|
Manufacturer Narrative
|
The c702 module serial number was (b)(6).
|
|
Manufacturer Narrative
|
Calibration was last performed on (b)(6) 2023 with acceptable results.Qc was acceptable.The field service engineer (fse) did not find a cause for the issue.The fse inspected the instrument and verified the sample probe adjustments were within specification.The customer performed successful qc.The investigation did not identify a product problem.The cause of the event could not be determined.
|
|
Search Alerts/Recalls
|