ELECSYS T4

Additional Manufacturer Narrative

FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND AN ISSUE WITH THE SPECIFIC REAGENT PACK. NO GENERAL REAGENT PROBLEM WAS FOUND. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: CALIBRATION AND QC WERE REVIEWED AND ACCEPTABLE. FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THIS INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLES WERE REQUESTED 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 22 PATIENTS FOR ELECSYS T4 FROM THREE COBAS E 801 MODULE ANALYZERS. 2. PATIENT AGE RANGE: 3 ARE 3 - 72 YEARS, 19 ARE ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1 FEMALE, 1 MALE, 20 ASKU. 5. PATIENT RACE BREAKDOWN: 2 ASIAN, 20 ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

FOR ONE OF THE EVENTS: SUMMARY OF INVESTIGATION RESULTS: THIS INVESTIGATION DETERMINED THE ISSUE IS RELATED TO THE REAGENT PACK. THE PACK WAS EITHER SUBJECTED TO LOW TEMPERATURES DURING THE LOGISTICAL CHAIN OF IT OR IT WAS IN AN INVERTED POSITION FOR A LONG PERIOD OF TIME. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW UP ACTIONS WERE TAKEN. FOR 1 OF THE EVENTS: SUMMARY OF INVESTIGATION RESULTS: NO INTERFERING FACTORS WERE IDENTIFIED. A GENERAL PRODUCT PROBLEM CAN BE EXCLUDED. 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. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLES WERE RECEIVED FOR INVESTIGATION.