ELECSYS DHEA-S

Additional Manufacturer Narrative

MEDWATCH FIELDS D1, D2, AND D4 HAVE BEEN UPDATED. SAMPLE MATERIAL WAS REQUESTED, HOWEVER, IT WAS NOT AVAILABLE. THEREFORE, FURTHER INVESTIGATION COULD NOT BE PERFORMED. THE ISSUE IS CONSISTENT WITH A KNOWN INTERFERING FACTOR MENTIONED IN THE PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF INTERFERENCE WITH THE ELECSYS DHEA-S, ELECSYS ESTRADIOL III ASSAY, AND ELECSYS TESTOSTERONE II ASSAY FOR A PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THIS MEDWATCH WILL APPLY TO THE ELECSYS DHEA-S ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ESTRADIOL III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TESTOSTERONE II ASSAY. BASED ON THE PREVIOUS RESULTS AND CONSIDERING THAT NOTHING WAS VISIBLE ON IMAGING AND THAT THE PATIENT STATED SHE WAS NOT TAKING ANY MEDICATION, THE DOCTOR REQUESTED THAT THE TESTS BE PERFORMED AT ANOTHER LABORATORY (ONE THAT USES CHEMILUMINESCENCE). THE FOLLOWING VALUES WERE OBTAINED AND WERE CONSIDERED NORMAL: (B)(6) 2026: ESTRADIOL 104 PG/ML, DHEA-S 90 G/DL, AND TESTOSTERONE 24 NG/DL. THE SAME SAMPLE WAS REPEATED AT THE CUSTOMER SITE AND GENERATED THE FOLLOWING RESULTS: ESTRADIOL 451 PG/ML, DHEA-S >1000 G/DL, AND TESTOSTERONE 126 NG/DL. A POLYETHYLENE GLYCOL (PEG) PRECIPITATION WAS PERFORMED AFTER MIXING EQUAL PARTS OF SERUM AND 25% W/V PEG, AND THE VALUES WERE: ESTRADIOL 170 PG/ML, DHEA-S 100 G/DL, AND TESTOSTERONE 30 NG/DL.