VITROS 3600 IMMUNODIAGNOSTICS SYSTEM
Received Feb 7, 2012 · Event occurred Jan 9, 2012
Report 1319681-2012-00020 · MDR key 2441282
Device
Product problems
- False Positive Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER OBSERVED FALSE (B)(6) VITROS ANTI-HBC (AHBC) RESULTS FROM TWO PATIENT SAMPLES ((B)(6)) USING THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM, WHEN COMPARED TO (B)(6) VITROS AHBC RESULTS PREDICTED FROM EACH SAMPLE APPROXIMATELY TWO MONTHS PRIOR. THE FALSE (B)(6) RESULTS WERE NOT REPORTED FROM THE LABORATORY. HOWEVER, A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF OCCURRED UNDETECTED. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED FALSE (B)(6) VITROS AHBC RESULTS WERE PREDICTED FROM TWO PATIENT SAMPLES WHEN TESTED ON A VITROS 3600 SYSTEM. INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE. NO MALFUNCTION OF THE VITROS AHBC REAGENT WAS IDENTIFIED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE INSTRUMENT RELATED. SERVICE ACTIONS WERE PERFORMED ON MULTIPLE INSTRUMENT SUBSYSTEMS. FOLLOWING THE SERVICE ACTIONS, CONCORDANT VITROS AHBC RESULTS WERE PREDICTED FROM 9 FRESH PATIENT SAMPLES WHEN COMPARED TO RESULTS PREDICTED FROM AN OUTSIDE LABORATORY ALSO USING VITROS AHBC REAGENT ON A VITROS 3600 SYSTEM.