ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER #2
Received Feb 10, 2000 · Event occurred Oct 1, 1998
Report MW1018124 · MDR key 262251
Device
Generic name
Software
Manufacturer
Abbott LaboratoriesModel number
FLEXIBLE PIPETTING CENTER #2Catalog number
*
Lot number
*
Product problems
- Use of Incorrect Control/Treatment Settings
- False Negative Result
- Application Program Problem: Parameter Calculation Error
Patient
*
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
HEPATITIS B SURFACE ANTIGEN TESTING. INITIAL INSTALLATION OF SOFTWARE WAS SET UP WITH DIFFERENT PARAMETERS INTENDED TO BE THE SAME. DIFFERENT SOFTWARE PARAMETERS RESULTED IN DIFFERENT CUT OFF LIMITS. APPROX 97 PTS WERE REPORTED AS NEGATIVE BUT COULD HAVE FALLEN IN AN INDETERMINATE RANGE. INDETERMINATE FINDINGS ARE ROUTINELY REPEATED AND MOST OFTEN FOUND TO BE NEGATIVE. STAFF RESEARCHING HOW MANY WERE RE-TESTED BECAUSE OF CONTINUED SYMPTOMS. PHYSICIAN NOTIFICATION UNDERTAKEN AND REPEAT TESTING WILL BE OFFERED. DIFFERENT SOFTWARE PARAMETERS WERE PRESENT PREVIOUSLY.