CLIN CHEM ALBUMIN BCG REAGENT
Received May 4, 2010 · Event occurred Mar 12, 2010
Report 2018433-2010-00072 · MDR key 1672835
Device
Generic name
Quantitation Of Albumin In Human Serum Or Plasma
Manufacturer
Abbott Manufacturing, Inc.Catalog number
7D53-21
Lot number
83030HW00
Product problems
- Nonstandard Device
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). AN INCORRECT SUSPECT MEDICAL DEVICE, LOT NUMBER, EXPIRATION DATE WAS SUBMITTED IN THE INITIAL MEDWATCH SUBMISSION. THE EXPIRATION DATE HAS BEEN CORRECTED TO 10/15/11. UPON FURTHER REVIEW, THE CUSTOMER'S ISSUE IS NOT ASSOCIATED WITH REMEDIAL ACTION (B)(4), AND IS UNASSIGNED.
Description of Event or Problem
THE CUSTOMER OBSERVED CLINICAL CHEMISTRY ALBUMIN BCG QUALITY CONTROL RESULTS BELOW PEER RANGE AFTER SWITCHING TO THE REFORMULATED ALBUMIN REAGENTS. THE CUSTOMER DID NOT OBSERVE THIS ISSUE WITH OTHER ASSAYS. THE CUSTOMER PROVIDED PRECISION DATA FOR EVALUATION AND ALSO PROVIDED THE FOLLOWING EXAMPLE OF PATIENT RESULTS AS FOLLOWS: ORIGINAL REAGENT: 4.35 G/DL, REFORMULATED REAGENT 4.57 G/DL. THE CUSTOMER ALSO PERFORMED SOME RECOMMENDED TROUBLESHOOTING AND WAS ASKED TO MONITOR THE ISSUE. 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