Siemens has requested instrument logs from the customer, however the customer has not provided the requested data.The cause of the multiple discrepancies could not be determined from the information provided by the customer.A review of the in-house performance for the card lot used, lot: 10-20082-20, did not identify any product deficiencies.The failure rate of lot: 10-20082-20 is not showing an increased trend in the field, therefore there is no further evidence that the system or reagent cards are not performing as intended.It should be noted that sample contamination, iv line contamination, or sample handling error can all contribute to multiple result discrepancies.The cause of this event is unknown.
|