ARCHITECT I2000SR ANALYZER
Received Dec 26, 2012 · Event occurred Dec 6, 2012
Report 1628664-2012-00515 · MDR key 2885213
Device
Manufacturer
Abbott Manufacturing IncCatalog number
03M74-01
Product problems
- False Positive Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A (B)(6)RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED A RESULT (B)(6). THE SAMPLE WAS RETESTED ON A VIDAS ANALYZER AND A NEGATIVE (B)(6) RESULT WAS GENERATED. THE (B)(6) RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Additional Manufacturer Narrative
THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A (B)(6) RESULT FOR ONE PATIENT SAMPLE. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. REVIEW OF THE MESSAGE HISTORY FOUND MULTIPLE LIQUID NOT FOUND AND ASPIRATION ERRORS FOR THE SAMPLE PIPETTOR. REPLACEMENT OF THE PROBE RESOLVED THE ISSUE. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS OR NON-STATISTICAL TRENDS FOR THE PROBE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.