ELECSYS DHEA-S

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS RECEIVED FOR INVESTIGATION. 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO 5. DEVICE REPROCESSED AND REUSED? NO

Description of Event or Problem

1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS DHEA-S ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: FEMALE, 5. PATIENT RACE BREAKDOWN: ASKU, 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE WAS DUE TO A DETECTED INTERFERENCE FACTOR IN THE SAMPLE. PER 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." AND "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW-UP/CORRECTIVE ACTIONS WERE TAKEN.