VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS, LOT 92980, USING VITROS NA+ SLIDE LOT 4254-1134-2585 ON A VITROS 350 CHEMISTRY SYSTEM. BIORAD LEVEL 1 NA+ RESULT OF 157.9 MMOL/L VS. THE BASELINE MEAN OF 121.3 MMOL/L BIORAD LEVEL 2 NA+ RESULT OF 122.2 MMOL/L VS. THE BASELINE MEAN OF 158.1 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER AND HIGHER THAN EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A LOWER AND HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS, LOT 92980, USING VITROS NA+ SLIDE LOT 4254-1134-2585 ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. PRE-ANALYTICAL SAMPLE MIX-UP CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT AS BOTH ERRONEOUS RESULTS ARE SIMILAR TO THE BASELINE MEAN OF THE ALTERNATE CONTROL IN USE, HOWEVER, THIS COULD NOT BE CONFIRMED. A PERFORMANCE ISSUE WITH VITROS NA+ SLIDE LOT 4254-1134-2585 CANNOT BE COMPLETELY RULED OUT AS HISTORICAL QUALITY CONTROL RESULTS INDICATED SOME IMPRECISION WITHIN THE TIMEFRAME OF THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS NA+ SLIDE LOT 4254-1134-2585. THE INVESTIGATION FOUND NO INDICATION THE VITROS 350 CHEMISTRY SYSTEM OR VITROS NA+ SLIDE LOT 4254-1134-2585 MALFUNCTIONED, AS ACCEPTABLE PERFORMANCE WAS OBTAINED USING AN ALTERNATE SLIDE LOT. THE ERRONEOUS RESULTS WERE ISOLATED TO A SINGLE CALIBRATION EVENT WITH ATYPICAL CALIBRATION RESPONSES AND PARAMETERS; THEREFORE, A SUBOPTIMAL CALIBRATION CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.