Catalog Number 443327 |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/14/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that while using bd totalys multiprocessor there is cross-contamination of the instrument causing an increased leukocyte count.No patient impact reported.The following information was provided by the initial reporter: "we have noticed that our samples got a lot of leukocytes the last few weeks.The amount of leukocytes on a slide is related to the sample itself.Most of the leukocytes are removed during the cell enrichment process in the multiprocessor.It did not concern erroneous results ¿ just messy results; obstructed with undesired cells.".
|
|
Event Description
|
It was reported that while using bd totals multiprocessor there is cross-contamination of the instrument causing an increased leukocyte count.No patient impact reported.The following information was provided by the initial reporter: "we have noticed that our samples got a lot of leukocytes the last few weeks.The amount of leukocytes on a slide is related to the sample itself.Most of the leukocytes are removed during the cell enrichment process in the multiprocessor.It did not concern erroneous results ¿ just messy results; obstructed with undesired cells.".
|
|
Manufacturer Narrative
|
It has been determined that mdr 1119779-2023-00825 was reported in error.There was no report of cross contamination.It did not concern erroneous results ¿ just messy results; obstructed with undesired cells.There was no report of serious injury, medical intervention, or reportable device malfunction, hence the event should be considered not reportable.
|
|
Search Alerts/Recalls
|