TOTAL PROTEIN GEN.2
Received May 23, 2011 · Event occurred Apr 20, 2011
Report 1823260-2011-02719 · MDR key 2098718
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03183734190
Lot number
63701701
Product problems
- Incorrect Or Inadequate Test Results
Patient
055 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Additional Manufacturer Narrative
THE CAUSE OF THIS EVENT WAS DETERMINED TO BE CUSTOMER HANDLING OF SAMPLE TUBES. THE CUSTOMER WAS CONTACTED REGARDING PROPER HANDLING OF SAMPLE TUES, NOT PLACING TALLER SAMPLE TUBES INTO RACKS DEDICATED TO BE USED WITH SHORTER TUBES, AND POURING SHORT SAMPLES INTO SAMPLE CUPS FOR TESTING.
Description of Event or Problem
THE USER STATED THEY WERE RECEIVING QUESTIONABLE TOTAL PROTEIN RESULTS ON THEIR COBAS C501 (SERIAL NUMBER (B)(4)). THE USER WAS ABLE TO PROVIDE DATA FOR TEN PATIENTS. OF THAT DATA, THERE WERE TWO DISCREPANT TOTAL PROTEIN RESULTS REPORTED OUTSIDE THE LABORATORY. ALL REPEATS WERE PERFORMED ON (B)(6) 2011 AND SENT OUT ON CORRECTED REPORTS. THE FIRST PATIENT HAD AN INITIAL RESULT OF 8.7 G/DL. THE REPEAT RESULT WAS 7.0 G/DL. THE SECOND PATIENT, A MALE BORN ON (B)(6), HAD AN INITIAL RESULT OF 1.6 G/DL. THE REPEAT RESULT WAS 6.9 G/DL. THERE WERE NO ADVERSE AFFECTS TO THE PATIENTS AS A RESULT OF THIS EVENT. THE USER DECLINED A SERVICE VISIT. THE USER BELIEVED THE PROBLEM WAS CAUSED BY A FAULTY PROBE THAT MAY HAVE BEEN PARTIALLY OCCLUDED BY GEL. HE CHANGED THE PROBE AND THERE HAVE BEEN NO FURTHER ISSUES.