TOTAL PROTEIN GEN.2

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. IT WAS NOTED THE ISSUE HAS NOT REOCCURRED SINCE THE USER BEGAN DISCARDING THE CUPS AND STOPPED REUSING EMPTY CUPS. GOOD LABORATORY PRACTICE IS ESSENTIAL TO THE GENERATION OF PLAUSIBLE PATIENT RESULTS. NONE OF THE PATIENTS WAS ADVERSELY AFFECTED IN THIS CASE.

Additional Manufacturer Narrative

OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

Description of Event or Problem

THE USER RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES THAT HAD BEEN ALIQUOTED BY THE MPA (MODULAR PREANALYTIC ANALYZER) THEN TESTED ON THE COBAS C501 ANALYZER SERIAL NUMBER (B)(4). DATA WAS PROVIDED FOR ONE PATIENT SAMPLE WHOSE RESULTS WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL TOTAL PROTEIN RESULT WAS 5.8 G/DL AND THE REPEAT RESULT FROM THE PRIMARY TUBE WAS 7.5 G/DL. THE PATIENT WAS NOT ADMITTED TO A MEDICAL FACILITY; TREATMENT WAS NOT PROVIDED, ALTERED OR WITHHELD DUE TO THE ERRONEOUS RESULTS THAT WERE REPORTED OUT. THE USER DECLINED A SERVICE VISIT AND STATED SHE WOULD MONITOR THE SITUATION. THE USER STATED THEY WERE TOLD NOT TO REUSE THE EMPTY CUPS LEFT IN THE RACKS AFTER PROCESSING BY THE MPA, BUT THEY DECIDED TO CHECK THE CUPS AND IF THEY LOOKED EMPTY, THEN THEY WOULD REUSE THE CUPS. THEY HAVE DISCONTINUED REUSING EMPTY CUPS THAT WERE LEFT IN THE RACKS AND HAVE NOT EXPERIENCED A REOCCURRENCE OF THE ISSUE.