CLIN CHEM ALBUMIN BCG REAGENT
Received Mar 26, 2010 · Event occurred Feb 9, 2010
Report 2018433-2010-00005 · MDR key 1641179
Device
Generic name
Quantitation Of Albumin In Human Serum Or Plasma
Manufacturer
Abbott Manufacturing, Inc.Catalog number
7D53-21
Lot number
80051HW00
Product problems
- Improper or Incorrect Procedure or Method
- High Test Results
- Calibration Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED CLINICAL CHEMISTRY ALBUMIN BCG QUALITY CONTROLS WERE OUT OF RANGE HIGH FOLLOWING CALIBRATION. THE CUSTOMER VERIFIED CALIBRATION SET POINTS AND REPEATED CALIBRATION WITHOUT RESOLUTION. THE CUSTOMER TECHNICAL ADVOCATE REQUESTED DATA TO REVIEW AFTER THE CUSTOMER PERFORMED TROUBLESHOOTING PROCEDURES WHICH FAILED TO RESOLVE THE ISSUE. THE CUSTOMER WAS UNWILLING TO TROUBLESHOOT THE PROBLEM FURTHER AND REQUESTED A SERVICE CALL. THE CUSTOMER DATA WAS EVALUATED AND IT WAS DETERMINED THE ASSAY PARAMETERS AND CALIBRATOR SET POINTS WERE CORRECT. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER ENTERED THE CORRECT CALIBRATOR CONCENTRATION VALUES IN THE CALIBRATION CONCENTRATION SCREEN AND USED THE CORRECT CALIBRATOR MATERIAL. A SUBSEQUENT SUCCESSFUL CALIBRATION WAS ACHIEVED AND QUALITY CONTROL VALUES WERE WITHIN SPECIFICATION. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCHITECT C8000 ANALYZER, LIST # 1G06-01, (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Recall