THE INVESTIGATION DETERMINED THAT DISCORDANT VITROS K RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM AND A VITROS 5600 INTEGRATED SYSTEM. THE LIKELY ASSIGNABLE CAUSE FOR THE EVENT IS PRE-ANALYTICAL SAMPLE HANDLING. THE CUSTOMER INDICATED THAT SAMPLE QUALITY IS AN ISSUE WITH SAMPLES OBTAINED FROM THE SATELLITE LAB. THE PATIENT SAMPLE INVOLVED IN THIS EVENT WAS OBTAINED FROM THE SATELLITE SITE. IT IS UNKNOWN IF THE PATIENT SAMPLE IN QUESTION WAS CENTRIFUGED ACCORDING TO THE TUBE MANUFACTURER?S RECOMMENDATIONS AND THEREFORE, IT WAS CONCLUDED THAT PRE-ANALYTICAL SAMPLE HANDLING WAS A LIKELY CONTRIBUTING FACTOR TO THE EVENT. BASED ON ACCEPTABLE HISTORICAL VITROS K+ QUALITY CONTROL DATA, A VITROS K+ REAGENT ISSUE WAS RULED OUT AS A CONTRIBUTING FACTOR. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUES WITH THE VITROS K+ LOT. ACCEPTABLE WITHIN RUN NA+ AND K+ PRECISION TESTS WERE PROCESSED ON BOTH VITROS SYSTEMS INDICATING AN INSTRUMENT ISSUE WAS NOT A CONTRIBUTING FACTOR. THERE IS NO EVIDENCE TO SUGGEST AN INSTRUMENT OR ASSAY RELATED ISSUE CONTRIBUTED TO THE EVENT.
D
Patient 1
THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS FROM A PATIENT SAMPLE PROCESSED USING A VITROS 4600 CHEMISTRY SYSTEM AND A VITROS 5600 INTEGRATED SYSTEM. VITROS K+ RESULTS 4.8, 4.8, AND 4.7 VERSUS THE EXPECTED 2.2 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE UNEXPECTED VITROS K+ RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).