ELECSYS FT3 III

Additional Manufacturer Narrative

D4 LOT NO CONTINUED: 82038002, 777784. FOR 4 OF THE EVENTS: SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. FOR 1 OF THE EVENTS: SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR 1 OF THE EVENTS: SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION WAS UNABLE TO DETERMINE A ROOT CAUSE DUE TO THE SAMPLE NOT BEING AVAILABLE FOR INVESTIGATION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS REQUESTED FOR INVESTIGATION, BUT THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. DEVICE RETURNED TO MANUFACTURER? NO. DEVICE LABELED "FOR SINGLE USE?" NO. DEVICE REPROCESSED AND REUSED? NO.

Description of Event or Problem

1. DESCRIBE THE EVENT: THERE WERE ALLEGATIONS OF DISCREPANT HIGH RESULTS FOR 6 PATIENTS TESTED FOR ELECSYS FT3 III. THE EVENTS INVOLVED 2 COBAS 8000 E 801 MODULES, 2 COBAS 8000 CORE UNITS, A COBAS 6000 E601 MODULE, AND A COBAS E 602 MODULE. 2. PATIENT AGE RANGE: 1 ASKU, 40 - 79 YEARS. 3. PATIENT WEIGHT RANGE: 6 ASKU. 4. PATIENT SEX BREAKDOWN: 2 ASKU, 4 FEMALES. 5. PATIENT RACE BREAKDOWN: 6 ASKU. 6. PATIENT ETHNICITY BREAKDOWN: 6 ASKU.

Additional Manufacturer Narrative

FOR 3 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DETERMINED THAT THE EVENT WAS DUE TO THE INTERFERENT IN THE PATIENT SAMPLE. PRODUCT LABELING STATES, "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. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION AND WERE ANALYZED FOR INTERFERENTS. INTERFERENTS TO THE ASSAY ANTIBODY WERE DETECTED IN THE PATIENT SAMPLES. FOR 1 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: IT WAS FOUND THAT THERE WERE BEADS IN THE REAGENT LID, WHICH SUGGESTS INADEQUATE REAGENT STORAGE CONDITIONS EITHER DURING TRANSPORT OR STORAGE AT THE CUSTOMER SITE. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A REAGENT TRANSPORT OR STORAGE ISSUE. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE CUSTOMER DISCARDED THE REAGENT KIT. FOR 1 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. PRODUCT LABELING STATES "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: THE PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION AND WERE ANALYZED FOR INTERFERENTS. NO INTERFERENT WAS DETECTED IN THE PATIENT SAMPLE.