CLINICAL CHEMISTRY PHOSPHORUS
Received Apr 5, 2017 · Event occurred Mar 17, 2017
Report 1628664-2017-00091 · MDR key 6460883
Device
Product problems
- Incorrect Measurement
- Incorrect Measurement
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. A REVIEW OF THE INSTRUMENT LOGS SHOWS 63 OCCURRENCES OF (B)(4). PROMPTLY PERFORM THE WASH CUVETTES PROCEDURE). USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER'S ISSUE AS THESE ERROR CODES INDICATE THE INSTRUMENT MAY HAVE DIRTY CUVETTES, WHICH COULD AFFECT THE OPTICAL READINGS. THE ARCHITECT CLIN CHEM PHOSPHORUS ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE RESULTS OF THIS EVALUATION AND THE INFORMATION FROM THE CUSTOMER SITE, A PRODUCT MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTS DISCREPANT CLIN CHEM PHOSPHORUS ASSAY RESULTS GENERATED ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING EXAMPLES WERE PROVIDED: SID (B)(6)= 4.1 AND 12.0 MG/DL; SID (B)(6)= 4.1 AND 14.0 MG/DL. CONTROLS WERE WITHIN SPECIFICATION. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.