ON (B)(6) 2016 A FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE CUSTOMER ON THE PHONE AND PROVIDED INSTRUCTIONS ON HOW TO CLEAN THE LEAD SCREW, GUIDE SHAFT, AND THE O-RINGS. FSE ADVISED THE CUSTOMER TO REPLACE THE SAMPLE NEEDLE SINCE THE ORIGINAL NEEDLE IS BENT. THE CUSTOMER TESTED THE INSTRUMENT BY RUNNING QUALITY CONTROLS (QC) AND PATIENT SAMPLES. ALL RESULTS WERE WITHIN ACCEPTABLE RANGE AND ENCOUNTERED NO ISSUES. THE G8 INSTRUMENT WAS FUNCTIONING AS INTENDED AND THE ERRORS CLEARED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. A COMPLAINT AND SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) WAS CONDUCTED FROM (B)(6) 2015 THROUGH (B)(6) 2016 FOR SIMILAR COMPLAINTS. THERE WAS ONE (1) SIMILAR COMPLAINT TO THE PRESENT ISSUE. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-(B)(4). (B)(4) IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER TOSOH CORPORATION, PER EXEMPTION NUMBER (B)(4). THE PROBABLE CAUSE OF THE EVENT WAS A DIRTY GUIDE SHAFT AND LEAD SCREW FOR Z-AXIS.
D
Patient 1
ON (B)(6) 2016 A CUSTOMER REPORTED ERROR 710 (Z1 AXIS ERRORS) WITH THE G8 ANALYZER. THE CUSTOMER STATED THAT CHANGING THE NEEDLE DID NOT RESOLVE THE ISSUE. THE CUSTOMER IS UNABLE TO RUN HBA1C IN THE PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.