VIDAS® NT-PRO BNP
Received Jun 2, 2016 · Event occurred Mar 25, 2016
Report 3002769706-2016-00098 · MDR key 5694686
Device
Product problems
- Component Missing
- Component Missing
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION INTO THIS EVENT WAS PERFORMED BY BIOMERIEUX. RETAIN KITS WERE VISUALLY INSPECTED FOR THE PRESENCE OF PROPER COMPONENTS. THE RETAIN KIT WAS FOUND TO HAVE FOUR(4) C2 VIALS AND ZERO C1 VIALS. THIS INSPECTION CONFIRMED THAT THERE WAS A PACKAGING ISSUE PRESENT WITHIN THIS LOT OF KITS. A CAPA HAS BEEN INITIATED TO DETERMINE EXACT ROOT CAUSE AND IMPLEMENT APPROPRIATE CORRECTIVE ACTIONS.
Description of Event or Problem
A CUSTOMER REPORTED A PACKAGING ERROR ASSOCIATED WITH THE VIDAST-PRO BNP (REF 30449-01). THE CUSTOMER RECEIVED FOUR (4) CONTAINERS OF C1 WITHIN THE PACKAGING BUT NO CONTAINERS OF C2. THERE IS NO INDICATION FROM THE CUSTOMER OF AN ADVERSE IMPACT ON TREATMENT NOR A DELAY IN TREATMENT OR RESULTS.