Model Number 393-800 |
Device Problems
Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)
|
Patient Problem
Hyperbilirubinemia (1903)
|
Event Date 05/31/2018 |
Event Type
Injury
|
Event Description
|
According to the complaint, a customer obtained a bilirubin result of 2.0 mg/dl on a neonate.From a comparison method applying architect 200, however with no data available, the concentration of bilirubin was reported to be approximately 11 mg/dl.
|
|
Manufacturer Narrative
|
Root cause for the issue is that hbf correction was disabled by the customer, even though it is stated in operator's manual that it should be enabled while conducting neonatal analyses.Neither death or serious injury have been reported.From the initial version of the existing event, malfunction was chosen as type of reportable event.However, as it is a matter of use error, no type of reportable event could be ticked off.
|
|
Manufacturer Narrative
|
By mistake, in 3002807968-2018-00043 follow-up 1 it was stated that no serious injury happened.Conclusively, the existing matter is a serious injury together with the fact that root cause for the issue was that hbf correction was disabled by the customer.
|
|
Search Alerts/Recalls
|