TPUC3

Additional Manufacturer Narrative

THE CUSTOMER STATED THERE WAS NO EVIDENCE OF GAMMOPATHY IN THE PATIENT. THE CUSTOMER STATED THAT THE 1:3 DILUTION WAS PERFORMED AS AN AUTOMATIC REPEAT BY THE ANALYZER. THE CUSTOMER STATED THAT DILUTIONS WERE PERFORMED TWICE MANUALLY BY DIFFERENT OPERATORS AND THE RESULTS WERE COMPARABLE. MEDWATCH FIELD D10 HAS BEEN UPDATED.

Additional Manufacturer Narrative

THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C702 ANALYZER IS (B)(6). THE REACTION DATA FROM THE ANALYZER WAS CHECKED AND FOR THE INITIAL VALUE, IT APPEARS THAT A HIGH DOSE HOOK EFFECT IS LIKELY. THE INITIAL REPEAT, 1:3, AND 1:5 DILUTION REACTIONS APPEARED UNSTABLE. THE 1:2 DILUTION VALUE HAD DECREASING ABSORBANCE AT THE END OF THE REACTION. CALIBRATION AND CONTROLS WERE ACCEPTABLE, SO A GENERAL REAGENT ISSUE CAN BE RULED OUT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN. 3 ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 3064 MG/L ACCOMPANIED BY A DATA FLAG INDICATING HIGH ABSORBANCE. THE SAMPLE WAS AUTOMATICALLY REPEATED, RESULTING IN A VALUE OF 1152 MG/L. THE SAMPLE WAS DILUTED 1:2 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 1591 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 3182 MG/L. THE SAMPLE WAS DILUTED 1:3 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 931 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 2793 MG/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 415 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 2075 MG/L. THE SAMPLE WAS DILUTED 1:10 AND REPEATED, RESULTING IN A RAW TOTAL PROTEIN VALUE OF 104 MG/L WHICH WAS CALCULATED TO A FINAL VALUE OF 1040 MG/L.