ARCHITECT BNP
Received Nov 3, 2017
Report 1415939-2017-00195 · MDR key 7000401
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02P14 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08K28. (B)(4) SPLASH TO A TECHNICIAN FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A DEVICE HISTORY REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN PARTS WERE NOT AVAILABLE. A DEVICE HISTORY REVIEW DID NOT FIND ANY ISSUES WITH THE PRODUCT IN QUESTION. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND OR NON-STATISTICAL TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT BNP ASSAY, LIST NUMBER 02P14 WAS IDENTIFIED.
Description of Event or Problem
WHILE REATTACHING THE CONTROL BOTTLE OF THE ARCHITECT BNP ASSAY LIQUID FROM THE BOTTLE DRIPPED OUT AND SPLASHED INTO THEIR EYES. THE TECHNICIAN FLUSHED THEIR EYES WITH WATER AND THE TECHNICIAN HAD THEIR EYES EXAMINED BY AN OPTHALMAOLOGIST. NO TREATMENT WAS ADMINISTERED. THE TECHNICIAN WAS NOT WEARING PROTECTIVE GLASSES.