Model Number C501 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/09/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
This event occurred in (b)(6).
|
|
Event Description
|
The customer received a questionable c-reactive protein (crp) result for one patient sample.The initial result was 1.138 mg/dl and was reported to doctor who hospitalized the patient.At the hospital, the patient was retested for crp and the result did not agree with the initial result.No specific data could be provided.On (b)(6) 2015, the doctor asked customer to repeat the test.The sample from (b)(6) 2015 was tested with a result of 0.354 mg/dl.Of the data provided, the ion selective electrode (ise) potassium results for the sample were also discrepant.The initial result on (b)(6) 2015 was 4.62 and the repeat result on (b)(6) 2015 was 5.21.The unit of measure was not provided.The patient was not adversely affected.The crp reagent lot number was 616063.The expiration date was requested, but was not provided.The potassium electrode lot number and expiration date were requested, but were not provided.As multiple assays gave differing results upon repeat testing, a general instrument issue was suspected.It was noted the customer was not using the recommended sample tube rack adapters which might have allowed the sample tube to lean and led to a pipetting issue.
|
|
Manufacturer Narrative
|
A specific root cause could not be identified, but a preanalytic issue was suspected.A general reagent issue was not likely.The field service representative cleaned the rinse arm nozzles and probes, checked the volumes being pipetted, the tubes, valves, photometer, and mixer.All were acceptable.
|
|
Search Alerts/Recalls
|
|