ELECSYS T4

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: 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. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS E801 ANALYTICAL UNIT AND FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS 8000 E 602 MODULE. 2. PATIENT AGE RANGE: ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: ASKU, 5. PATIENT RACE BREAKDOWN: ASKU, 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

FOR 1 OF THE EVENTS: SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A PRE-ANALYTICAL ISSUE (A CLOT WAS DETECTED IN THE SAMPLE) AT THE CUSTOMER'S SITE. PRE-ANALYTICAL IS WITHIN THE CUSTOMER'S RESPONSIBILITY. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE ANALYZER WAS CHECKED AND NO PROBLEM WAS FOUND. FOR 1 OF THE EVENTS: SUMMARY OF INVESTIGATION RESULTS: A GENERAL REAGENT ISSUE CAN BE EXCLUDED, AS A DIFFERENT REAGENT KIT FROM THE SAME LOT PERFORMED ACCORDING TO EXPECTATIONS AT THE CUSTOMER SITE. THE CUSTOMER DID NOT PERFORM QC ON THE REAGENT BEFORE USE. PER PRODUCT LABELING: "CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER COBAS E PACK, AND FOLLOWING EACH CALIBRATION." THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THE EVENT IS CONSISTENT WITH A STORAGE OR TRANSPORTATION ISSUE. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE CUSTOMER REPLACED THE REAGENT PACK AND THE ISSUE WAS RESOLVED.