VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
Received Dec 23, 2010 · Event occurred Nov 30, 2010
Report 1319681-2010-00291 · MDR key 1936676
Device
Product problems
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER OBSERVED A FALSE NEGATIVE ANTI-HBC CONTROL FLUID RESULT ON THE VITROS ECIQ ANALYZER. BIASED PATIENT SAMPLE RESULTS DID NOT OCCUR. HOWEVER, IF BIASED RESULTS OF THE MAGNITUDE AND DIRECTION WERE OBSERVED ON PATIENT SAMPLES, IT COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)
Additional Manufacturer Narrative
THE INVESTIGATION HAS DETERMINED THAT A FALSE NEGATIVE ANTI-HBC CONTROL FLUID RESULT OCCURRED ON A VITROS ECIQ ANALYZER. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED, AS THE CUSTOMER DID NOT WANT TO CONTINUE THE INVESTIGATION. IT COULD NOT BE CONFIRMED THAT THE VITROS ANTI-HBC REAGENT, CONTROLS OR ECIQ ANALYZER WERE PERFORMING AS EXPECTED WITH THE LIMITED INFORMATION PROVIDED. ACCEPTABLE VITROS ANTI-HBC CONTROL FLUID RESULTS WERE OBTAINED USING AN ALTERNATE LOT OF VITROS ANTI-HBC CONTROL FLUIDS AND AN ALTERNATE LOT OF VITROS ANTI-HBC REAGENT.