THE INVESTIGATION HAS DETERMINED THAT A LOWER THAN EXPECTED VITROS VALP RESULT WAS OBTAINED FROM A SINGLE PATIENT CORRELATION SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT, LOT 2511-25-5727 ON VITROS 5600 INTEGRATED SYSTEM S/N (B)(4). THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN, HOWEVER, IMPROPER PRE ANALYTICAL SAMPLE STORAGE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IT IS UNKNOWN IF THE AFFECTED SAMPLE WAS STORED USING THE PROTOCOL STATED IN THE VITROS CHEMISTRY PRODUCTS VALP REAGENT INSTRUCTIONS FOR USE. IN ADDITION, A CALIBRATION RELATED ISSUE OR AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE ISSUE WAS RESOLVED AFTER PERFORMING THE ROUTINE MAINTENANCE ACTIONS OF REPLACING THE PHOTOMETER LAMP, PERFORMING A WATER BLANK PROCEDURE, AND RECALIBRATING VITROS CHEMISTRY PRODUCTS VALP REAGENT, LOT 2511-25-5727.
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Patient 1
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT A LOWER THAN EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT CORRELATION SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 2 RESULT OF 24 UG/ML VERSUS AN EXPECTED RESULT OF 34.0 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER MADE NO INDICATION THAT ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).