TG G2 ELECSYS COBAS E 100 V2

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: DUE TO THE LIMITED INFORMATION ABOUT THE ISSUE, THE INVESTIGATION WAS NOT ABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THERE WERE NO FOLLOW UP/CORRECTIVE ACTIONS.

Description of Event or Problem

1. THERE WAS AN ALLEGATION OF QUESTIONABLE TG G2 ELECSYS RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 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

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.