TOSOH ST AIA-PACK BHCG
Received Apr 16, 2013 · Event occurred Apr 9, 2013
Report 3005529799-2013-00005 · MDR key 3069378
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(4) 2013, TOSOH BIOSCIENCE, INC. WAS NOTIFIED BY A CUSTOMER LABORATORY THAT ON (B)(6)2013 AN ERRONEOUS BHCG PATIENT RESULT WAS REPORTED AS <L (<5.0 MIU/ML). THIS RESULT WAS NOT QUESTIONED BY THE PHYSICIAN AND THE LAB INDICATED THAT ALL QC WERE WITHIN EXPECTED RANGES. THE PATIENT SAMPLE WAS THE FIRST ONE RUN AFTER QUALITY CONTROL AND THE LABORATORY PROTOCOL IS TO REPEAT ALL FIRST RUN PATIENT SAMPLES OF THE DAY AS A "CONTROL" AT THE END OF THAT SAME DAY. THIS WAS DONE AND THE BHCG RESULT WAS 441 MIU/ML. DUE TO THE DISCREPANCY IN VALUES IT WAS REPEATED AND THE RESULT WAS 46 MIU/ML. THE PATIENT SAMPLE WAS EXAMINED FOR THE PRESENCE OF FIBRIN AND NONE WAS OBSERVED.
Additional Manufacturer Narrative
ON (B)(6), AS PART OF THE INVESTIGATION, A PRECISION STUDY (N=15), WAS ALSO PERFORMED ON THE PATIENT SAMPLE, AND THE RESULTS WERE; 47, 46, 44, 46, 47, 46, 47, 47, 45, 46, 45, 48, 47, 47, 48. ON (B)(6), A CORRECTED REPORT WAS THEN SENT TO THE PATIENT WITH A FINAL RESULT OF 44 MIU/ML. IT WAS CONFIRMED THAT THE PATIENT WAS NOT TREATED BASED ON THE INITIAL REPORT AND THERE WAS NO HARM TO THE PATIENT. ON (B)(6) 2013, THE PATIENT WAS ALSO INFORMED OF THE CORRECTED RESULT. ROOT CAUSE: NOT CONFIRMED BUT SINCE THIS ONLY OCCURRED ON ONE SPECIMEN IT IS SUSPECTED THAT IT WAS A SPECIMEN ISSUE, POSSIBLY A FIBRIN CLOT THAT PREVENTED ACCURATE ANALYSIS ON THE INITIAL RUN.