VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY REGENT
Received Dec 20, 2002 · Event occurred Nov 21, 2002
Report 9680658-2002-00204 · MDR key 434540
Device
Generic name
In Vitro Diagnostic
Manufacturer
Ortho-clinical DiagnosticsModel number
NACatalog number
8228595
Lot number
121
Product problems
- False Negative Result
- Improper or Incorrect Procedure or Method
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER OBTAINED A FALSE NEGATIVE INTERPRETATION FOR A HBV POSITIVE PATIENT SAMPLE USING THE HBSAG CONFIRMATORY KIT. THE SAMPLE WAS RETESTED USING THE CORRECT PROTOCOL AND A POSITIVE RESULT WAS OBTAINED. A FALSE NEGATIVE RESULT COULD CAUSE THE PHYSICIAN NOT TO INITIATE PROPER TREATMENT OR PRESENT A RISK TO PUBLIC HEALTH. THE CAUSE OF THIS EVENT IS USER ERROR (FAILURE TO FOLLOW PROTOCOL PROVIDED IN PACKAGE INSERT). NO FALSE NEGATIVE RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT HARM OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.