VITROS IMMUNODIAGNOSITC PRODUCTS HBSAG CONFIRMATORY KIT
Received Jun 12, 2006
Report 9680658-2006-00130 · MDR key 812442
Device
Generic name
In Vitro Diagnostic
Manufacturer
Ortho-clinical DiagnosticsModel number
NACatalog number
8228595
Lot number
270
Product problems
- False Negative Result
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER OBSERVED A FALSE NEGATIVE HBSAG CONFIRMATORY TEST RESULT ON A PATIENT SAMPLE ON THE ECI ANALYZER. POSITIVE RESULTS WERE OBTAINED USING AN ALTERNATE METHOD. THE ERRONEOUS RESULT WAS NOT REPORTED. FALSE NEGATIVE HBSAG CONFIRMATORY RESULTS COULD PRESENT A RISK TO PUBLIC HEALTH. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY. INVESTIGATION INTO THE EVENT SHOWED THAT THE SAMPLE WAS HBSAG CONFIRMED POSITIVE BY AN ALTERNATE METHOD CONFIRMATORY TEST. THE INITIAL CONFIRMATORY TEST PRODUCED NEUTRALIZATION OF LESS THAN 50%. THE CUSTOMER DID NOT COMPLETE THE CONFIRMATORY TESTING AS DESCRIBED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A MUTANT STRAIN OF THE VIRUS HAS BEEN IDENTIFIED IN THE CASE, THE ROOT CAUSE OF THE FALSE NEGATIVE CONFIRMATORY TEST HAS NOT BEEN IDENTIFIED.