| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FREEDOM EVO 200 MCA | PIPETTING STATION FOR CLINICAL USE | TECAN SCHWEIZ AG | JQW | EVO 200 | 30020020 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-06-21 | 0 | 1. O |
Patient 1
CUSTOMER REPORTED DURING VALIDATION TESTING OF THE INSTRUMENT IN THEIR LABORATORY THAT THE AIR LIQUID HANDLING PIPETTING ARM WAS EXPELLING WATER OUT OF THE REMAINING SAMPLE FROM THE DISPENSING TIPS AFTER DISPENSING AND LIFTING OF THE TIP CHANNEL. THE DROPLETS OF FLUID COULD CAUSE CROSS CONTAMINATION OF SAMPLES ON THE INSTRUMENT DECK. NO PATIENT RESULTS WERE GENERATED ON THE INSTRUMENT. THE INSTRUMENT WAS NOT IN ROUTINE USE.
Patient 1
(B)(4)N SERVICE REPRESENTATIVES EVALUATED THE CUSTOMER'S REPORT BOTH AT CUSTOMER'S SITE AND THROUGH A REVIEW OF INSTRUMENT LOG FILES AND CUSTOMER'S PROGRAM SCRIPT. TWO SOFTWARE BUGS WERE DETECTED IN THE INSTRUMENT'S APPLICATION SOFTWARE (B)(4) V2.5 WITH SERVICE PACK 3. BOTH ISSUES WERE INTRODUCED WHEN SERVICE PACK 3 WAS RELEASED ON APRIL 03, 2013. THE SOFTWARE ISSUES AFFECT FREEDOM EVO INSTRUMENTS CONFIGURED WITH AN AIR FILLED LIQUID HANDLING ARM RUNNING (B)(4) SOFTWARE V2.5 IN CONJUNCTION WITH SERVICE PACK 3. INSTRUMENTS NOT IN THIS CONFIGURATION ARE UNAFFECTED. THE SOFTWARE ISSUES RESULT IN PIPETTING ERRORS THAT CAN LEAD TO SAMPLE MIX UP AND CROSS CONTAMINATION. THERE HAVE BEEN NO COMPLAINTS OF INSTRUMENTS USED IN CLINICAL DIAGNOSTICS WHERE THESE SOFTWARE ISSUES HAVE CONTRIBUTED TO SAMPLE MIX UP OR CROSS CONTAMINATION RESULTING IN AN IMPACT TO PATIENT RESULTS SINCE THE RELEASE OF (B)(4) SERVICE PACK 3. A FIELD CORRECTIVE ACTION WILL BE INITIATED TO CORRECT THE SOFTWARE ERRORS AND CUSTOMERS WILL BE NOTIFIED. A CAPA IS OPEN TO INVESTIGATE ROOT CAUSE OF THE SOFTWARE ISSUES.