THE INVESTIGATION DETERMINED THAT A DISCORDANT, NEGATIVE VITROS OP-LO RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM. THE INTENDED USE SECTION OF THE VITROS OP IFU STATES THAT THE VITROS CHEMISTRY PRODUCT OP ASSAY IS INTENDED FOR USE BY PROFESSIONAL LABORATORY PERSONNEL. IT PROVIDES ONLY A PRELIMINARY TEST RESULT. A MORE SPECIFIC ALTERNATIVE CHEMICAL METHOD MUST BE USED TO CONFIRM A RESULT OBTAINED WITH THE VITROS OP ASSAY. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GCMS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG-OF-ABUSE TEST RESULT. THE LIKELY CAUSE IS A KNOWN LIMITATION OF THE VITROS OP REAGENT RELATED TO LOW CROSS REACTIVITY WITH OXYMORPHONE. THERE IS NO EVIDENCE THAT AN INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT. THE CUSTOMER?S CALIBRATION OF THE VITROS OP-LO REAGENT IN USE AT THE TIME OR AN UNIDENTIFIED REAGENT ISSUE COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS.
D
Patient 1
THE CUSTOMER OBTAINED A DISCORDANT, NEGATIVE VITROS OP-LO RESULT FROM A SINGLE PATIENT SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM, WHEN COMPARED TO A POSITIVE OPIATE RESULT OBTAINED USING THE GC/MS METHOD. VITROS PATIENT RESULT: 277 NG/ML (POSITIVE CUTOFF >OR = 300 NG/ML) VS. >12000 NG/ML (POSITIVE). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. IT IS NOT KNOWN IF THE DISCORDANT VITROS OP-LO RESULT WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF TREATMENT STARTED, STOPPED, OR ALTERED BASED ON THE FALSE NEGATIVE VITROS OP-LO RESULT AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).