Catalog Number 03L79-21 |
Device Problem
High Test Results (2457)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/25/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
|
|
Event Description
|
The customer reported multiple false elevated architect calcium results on the architect c16000 analyzer.Sample id 9175964jp generated an initial result of 5.13 mmol/l and retest of 2.20 mmol/l.No adverse impact to patient management was reported.
|
|
Manufacturer Narrative
|
Review of complaint activity for lot 98314un17 did not identify an increase in complaint activity.Tracking and trending report review for the architect calcium assay did not identify any adverse or non-statistical trends that require further investigation.Manufacturing documentation for the assay did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect calcium assay was identified.
|
|
Search Alerts/Recalls
|