VITROS CHEMISTRY PRODUCTS PHBR SLIDES
Received Jan 30, 2008 · Event occurred Jan 5, 2008
Report 1319809-2008-00025 · MDR key 988653
Device
Generic name
In-vitro Diagnostic
Manufacturer
Ortho-clinical Diagnostics, Inc.Model number
NACatalog number
822-1384
Lot number
2524-034-7449
Product problems
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CALIBRATED PHBR AND OBTAINED NEGATIVELY BIASED PHBR QC RESULTS ON THEIR VITROS 5, 1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT THE VITROS 5,1 WAS OPERATING AS EXPECTED. THE BIASED PHBR QC RESULTS WERE DUE TO USER ERROR AS THE INCORRECT CALIBRATOR KIT WAS SELECTED WHEN PROGRAMMING THE PHBR CALIBRATION.