TOTAL PROTEIN GEN.2

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ACCORDING TO THE INFORMATION PROVIDED, THE CUSTOMER BELIEVES THAT THE SAMPLE ALIQUOT CUP MAY HAVE BEEN REUSED AND MAY HAVE BEEN CONTAMINATED WITH ANOTHER SAMPLE. GOOD LABORATORY PRACTICE IS ESSENTIAL TO GENERATE PLAUSIBLE PATIENT RESULTS. NO ADVERSE EVENTS WERE REPORTED.

Description of Event or Problem

A REGIONAL APPLICATION SPECIALIST WAS NOTIFIED THAT A CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE INVOLVING MULTIPLE ASSAYS. THE ASSAYS THAT WERE ERRONEOUS AND WERE REPORTED OUTSIDE THE LABORATORY WERE GLUCOSE, CREATININE AND TOTAL PROTEIN. ALL TESTING WAS PERFORMED ON A COBAS 6000 C501 ANALYZER, SERIAL NUMBER (B)(4). THE INITIAL TOTAL PROTEIN RESULT WAS 9.1 G/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE OPERATOR QUESTIONED THE RESULTS OF A DIFFERENT ASSAY GENERATED FROM THIS SAMPLE AND PULLED THE SAMPLE TO REPEAT IT. THE REPEAT RESULT WAS 7.7 G/DL AND WAS ALSO REPORTED OUTSIDE THE LABORATORY IN A CORRECTED REPORT. THE PATIENT WAS NOT TREATED OR HARMED BASED ON THE ERRONEOUS RESULT. THE CUSTOMER BELIEVED THE SAMPLE CUP WAS NOT PROPERLY DISCARDED BY THE OPERATOR AFTER USE AND MAY HAVE BEEN CONTAMINATED BY ANOTHER SAMPLE. SHE COACHED THE APPROPRIATE PERSONNEL TO AVOID FUTURE ISSUES. THE REGIONAL APPLICATION SPECIALIST DID NOT DETERMINE THE CAUSE OF THE DISCREPANCIES. SHE CONCLUDED IT WAS POSSIBLE THAT THE PATIENT SAMPLE WAS PIPETTED INTO AN ALREADY USED CUP. SHE ADVISED THE CUSTOMER TO TOSS ALL THE CUPS AFTER USE.

Additional Manufacturer Narrative

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