VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

ORTHO HAS CONFIRMED AN ISSUE INVOLVING VITROS XT CHEMISTRY PRODUCTS ALB-TP SLIDES WHICH MAY CREATE DUST AND DEBRIS WITHIN THE MICROSLIDE SUBSYSTEM ON VITROS XT 3400 CHEMISTRY SYSTEMS AND VITROS XT 7600 INTEGRATED SYSTEMS. DUST AND DEBRIS FROM XT ALB-TP SLIDES MAY IMPACT VITROS CHEMISTRY PRODUCTS NA+ SLIDES LEADING TO A POTENTIAL INCREASE IN NON-REPRODUCIBLE, POSITIVELY, OR NEGATIVELY BIASED NA+ RESULTS. THIS SUPPLEMENTAL MDR WAS CREATED TO ASSOCIATE THE ISSUE FOR DUST AND DEBRIS FROM VITROS XT ALB-TP SLIDES PROCESSED ON VITROS XT SYSTEMS AS A POTENTIAL CONTRIBUTOR TO THIS REPORTABLE EVENT. THE FDA WAS NOTIFIED OF THIS ISSUE ON 16 JULY 2024. PLEASE REFER TO REPORT # (B)(4). ORTHO SENT A NOTIFICATION (CL2024-139) TO CUSTOMERS ON 10 JULY 2024. THE NOTIFICATION INFORMED CUSTOMERS THAT ORTHO WILL BE PAUSING AVAILABILITY OF THE VITROS XT ALB-TP SLIDES AND WILL SHIFT ALL AFFECTED CUSTOMERS TO THE INDIVIDUAL VITROS CHEMISTRY PRODUCTS ALB SLIDES AND TP SLIDES. IN ADDITION, ORTHO PROVIDED RECOMMENDED CLEANING STEPS AND FREQUENCY OF CLEANING IN THE NOTIFICATION. UPDATED UDI NUMBER IS (B)(4).

Description of Event or Problem

THIS SUPPLEMENTAL MDR WAS CREATED TO ASSOCIATE THIS REPORTABLE EVENT WITH AN ISSUE ORTHO HAS IDENTIFIED FOR DUST AND DEBRIS FROM VITROS XT ALB-TP SLIDES THAT MAY IMPACT VITROS NA+ SLIDES LEADING TO A POTENTIAL INCREASE IN NON-REPRODUCIBLE, POSITIVELY OR NEGATIVELY BIASED NA+ RESULTS. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 2626875 AND REPORTABILITY ASSESSMENT 606569.

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4232-1118-5512 ON A VITROS XT 7600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS NA+ LOT 4232-1118-5512 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. HOWEVER, AN INDIVIDUAL SLIDE RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR. THE RESULTS OF VITROS NA+ DIAGNOSTIC PRECISION TESTING PERFORMED ON THE VITROS XT 7600 SYSTEM WERE WITHIN ORTHO ACCEPTABLE GUIDELINES INDICATING THAT THE ANALYZER WAS PERFORMING WITHIN EXPECTATIONS. HOWEVER, AS THE CUSTOMER CLEANED THE EVAPORATION CAPS AND TIP LOCATOR PRIOR TO THE TESTING, AN INSTRUMENT RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS IT IS UNKNOWN IF THE SAMPLE COLLECTION DEVICE MANUFACTURER'S RECOMMENDED CENTRIFUGATION PROTOCOL WAS PROPERLY FOLLOWED. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4232-1118-5512.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4232-1118-5512 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 135 MMOL/L VS THE EXPECTED RESULT OF 125 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. BASED ON THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS NA+ RESULT THAT WAS REPORTED, ONGOING TREATMENT FOR THE CORRESPONDING PATIENT WAS SUSPENDED. PER A MEDICAL CONSULTATION WITH AN ORTHO MEDICAL SAFETY OFFICER ON 20 JUNE 2024: SERIOUS ACUTE OR LONG-TERM PATIENT INJURY IS NOT ANTICIPATED DUE TO THE EVENT. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).