TOTAL PROTEIN
Received Dec 17, 2014 · Event occurred Oct 20, 2014
Report 1823260-2014-10072 · MDR key 4338515
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04657586190
Lot number
692946
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT WAS CONFIRMED THAT NO PATIENTS WERE ADVERSELY AFFECTED.
Additional Manufacturer Narrative
THE CORRECT C111 ANALYZER SERIAL NUMBER USED AT THIS SITE HAS BEEN CONFIRMED TO BE (B)(4).
Additional Manufacturer Narrative
COMPARISON STUDIES HAVE BEEN PERFORMED AS A PART OF THE INVESTIGATION. PRELIMINARY INVESTIGATIONS HAVE BEEN ABLE TO VERIFY THE CUSTOMER'S COMPLAINT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE HIGH TOTAL PROTEIN RESULTS FOR A TOTAL OF 15 PATIENT SAMPLES WHEN COMPARED TO RESULTS FROM A BIOSYSTEMS BTS-350 ANALYZER. OF THE 15 SAMPLES, EIGHT OF THESE HAD ERRONEOUS RESULTS. THE CUSTOMER STATED THAT THEY SWITCHED TO A NEW REAGENT LOT NUMBER AND THEN OBTAINED THE CORRECT RESULTS FOR PATIENT SAMPLES. THE FIRST PATIENT SAMPLE INITIALLY RESULTED AS 80.8 G/L ON THE C111 ANALYZER. THE SAMPLE WAS REPEATED ON THE BIOSYSTEMS BTS-350 ANALYZER AND RESULTED AS 67.3 G/L. THE SECOND PATIENT SAMPLE INITIALLY RESULTED AS 80.2 G/L ON THE C111 ANALYZER. THE SAMPLE WAS REPEATED ON THE BIOSYSTEMS BTS-350 ANALYZER AND RESULTED AS 67.9 G/L. THE THIRD PATIENT SAMPLE INITIALLY RESULTED AS 86.4 G/L ON THE C111 ANALYZER. THE SAMPLE WAS REPEATED ON THE BIOSYSTEMS BTS-350 ANALYZER AND RESULTED AS 75.6 G/L. THE FOURTH PATIENT SAMPLE INITIALLY RESULTED AS 87 G/L ON THE C111 ANALYZER. THE SAMPLE WAS REPEATED ON THE BIOSYSTEMS BTS-350 ANALYZER AND RESULTED AS 76.5 G/L. THE FIFTH PATIENT SAMPLE INITIALLY RESULTED AS 82.9 G/L ON THE C111 ANALYZER. THE SAMPLE WAS REPEATED ON THE BIOSYSTEMS BTS-350 ANALYZER AND RESULTED AS 69 G/L. THE SIXTH PATIENT SAMPLE INITIALLY RESULTED AS 82.9 G/L ON THE C111 ANALYZER. THE SAMPLE WAS REPEATED ON THE BIOSYSTEMS BTS-350 ANALYZER AND RESULTED AS 69.5 G/L. THE SEVENTH PATIENT SAMPLE INITIALLY RESULTED AS 86.3 G/L ON THE C111 ANALYZER. THE SAMPLE WAS REPEATED ON THE BIOSYSTEMS BTS-350 ANALYZER AND RESULTED AS 75.3 G/L. THE EIGHTH PATIENT SAMPLE INITIALLY RESULTED AS 83.1 G/L ON THE C111 ANALYZER. THE SAMPLE WAS REPEATED ON THE BIOSYSTEMS BTS-350 ANALYZER AND RESULTED AS 67.5 G/L. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. A CLARIFICATION HAS BEEN REQUESTED. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY PATIENTS WERE ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. A C111 INSTRUMENT SERIAL NUMBER OF (B)(4) WAS PROVIDED, BUT IT IS NOT CLEAR IF THIS IS THE ACTUAL SERIAL NUMBER OF THE INSTRUMENT USED AT THIS SITE. A CLARIFICATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative
IT WAS DETERMINED THAT DURING THE PRELIMINARY INVESTIGATION METHOD COMPARISONS, SAMPLES USED FOR THE INVESTIGATION MEASUREMENTS WERE NOT CENTRIFUGED PRIOR TO MEASUREMENT. THE CUSTOMER'S COMPLAINT WAS VERIFIED AT THAT TIME. LABELING INDICATES THAT SAMPLES CONTAINING PRECIPITATES SHOULD BE CENTRIFUGED PRIOR TO MEASUREMENT. THE TOTAL PROTEIN ASSAY IS VERY SENSITIVE TO PRECIPITATES IN HUMAN SAMPLES. INVESTIGATION MEASUREMENTS WERE LATER PERFORMED WITH SAMPLES THAT HAD BEEN CENTRIFUGED AND RESULTS FROM THESE SAMPLES WERE WITHIN SPECIFICATIONS. A SPECIFIC ROOT CAUSE FOR THE CUSTOMER'S ISSUE COULD NOT BE IDENTIFIED.