BD MULTI-CHECK

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD MULTI-CHECK CONTROL THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE R&D MULTI-CHECK CONTROLS (349701 AND 349704) COME DIRECTLY FROM R&D, THE 2D BARCODE CAN BE READ BY THE FACSDUET. BUT WHEN THE R&D CONTROLS ARE REPACKAGED FOR BDB THE QR BARCODE ON THE TUBE IS NOT COMPATIBLE WITH THE DUET.

Additional 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.

Additional Manufacturer Narrative

H.6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF FAILED BAR CODE RECOGNITION WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: APPROVED ARTWORK FOR THE MULTICHECK CONTROL PRODUCT WAS OBTAINED AND PRINTED SUCCESSFULLY AT BDB. DOCUMENTATION FOR RECENT LOTS OF PART LOT 349704 WAS REVIEWED AND FOUND FREE OF NON-CONFORMANCES. AN ISOLATED REPORT OF FAILED BAR CODE RECOGNITION SUGGESTS MALFUNCTION OF THE CUSTOMER¿S INSTRUMENTATION SYSTEM. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD MULTI-CHECK CONTROL THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE R&D MULTI-CHECK CONTROLS (349701 AND 349704) COME DIRECTLY FROM R&D, THE 2D BARCODE CAN BE READ BY THE FACSDUET. BUT WHEN THE R&D CONTROLS ARE REPACKAGED FOR BDB THE QR BARCODE ON THE TUBE IS NOT COMPATIBLE WITH THE DUET.