ELECSYS FT3 III

Additional Manufacturer Narrative

FOR ONE OF THE PENDING EVENTS: SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND THE PATIENT SAMPLE CONTAINED AN INTERFERENCE TO THE STREPTAVIDIN COMPONENT OF THE ASSAY. 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. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. FOR ONE OF THE PENDING EVENTS: SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND THE PATIENT SAMPLE CONTAINED AN INTERFERENCE TO THE SURU LABEL OF THE ASSAY. 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. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION.

Additional Manufacturer Narrative

FOR ONE OF THE PENDING EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND THE PATIENT SAMPLE CONTAINED AN INTERFERENCE TO THE SURU LABEL OF THE ASSAY. 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. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. FOR ONE OF THE PENDING EVENTS: FOR THIS EVENT, THE INVESTIGATION STATED INSTRUMENT MAINTENANCE WAS PERFORMED. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. BASED ON THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE FOLLOW UP/CORRECTIVE ACTIONS TAKEN WERE THAT FIELD SERVICE VISITED THE CUSTOMER SITE AND THE CUSTOMER HAD NO FURTHER ISSUES. FOR ONE OF THE PENDING EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND THE PATIENT SAMPLE CONTAINED NO INTERFERING FACTORS AGAINST A COMPONENT OF THE FT3 ASSAY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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: A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. FOR ONE OF THE PENDING EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND THE PATIENT SAMPLE CONTAINED NO INTERFERING FACTORS AGAINST A COMPONENT OF THE FT3 ASSAY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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: A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. FOR ONE OF THE PENDING EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND THE PATIENT SAMPLE CONTAINED AN INTERFERENCE TO THE STREPTAVIDIN COMPONENT OF THE ASSAY. 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. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. FOR 2 EVENTS, THE INVESTIGATION IS ONGOING. 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. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 6 PATIENTS ON A COBAS E 801 MODULE, 1 PATIENT SAMPLE ON A COBAS 8000 CORE UNIT, AND 1 PATIENT SAMPLE COMPARED TO A COMPETITOR METHOD. 2. PATIENT AGE RANGE: 41 YEARS, 35 YEARS, 45 YEARS, 78 YEARS, 41 YEARS, 14 YEARS, ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 3 FEMALE, ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

FOR 7 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR 1 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: SINCE THE SAMPLE WAS NOT PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. FOR ALL OF THE EVENTS: 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" 5. DEVICE REPROCESSED AND REUSED? D4 LOT NO, CONTINUED: 78159803.