PHOS2 PHOSPHATE (INORGANIC) VER.2

Additional Manufacturer Narrative

THE PHOS2 REAGENT WITH LOT NUMBER 469807 WAS LOADED ON (B)(6) 2020. THIS REAGENT LOT WAS REMOVED ON (B)(6) 2021 FOR TROUBLESHOOTING PURPOSES. THE STANDBY REAGENT LOT NUMBER WAS 483585 WITH AN EXPIRATION DATE OF 31-AUG-2021. THIS REAGENT LOT WAS LOADED ON (B)(6) 2021. CALIBRATION WAS LAST PERFORMED ON 05-JAN-2021 (LOT 469807) AND ON 06-JAN-2021 (LOT 483585) AND WAS ACCEPTABLE. THE CUSTOMER¿S QC WAS WITHIN RANGE ON (B)(6) 2021 AND (B)(6) 2021. ON (B)(6) 2021 THE CUSTOMER¿S QC WAS OUT OF RANGE HIGH. THE CUSTOMER RECALIBRATED BOTH REAGENT LOTS AND QC WAS BACK WITHIN THE SPECIFIED RANGES. ON (B)(6) 2021 THE CUSTOMER¿S QC WAS OUT OF RANGE LOW. THE CUSTOMER RECALIBRATED THE STANDBY REAGENT LOT AND QC WAS BACK WITHIN THE SPECIFIED RANGES. ON 10-JAN-2021 THE CUSTOMER¿S QC WAS WITHIN RANGE. TWO "ABNORMAL SAMPLE ASPIRATION" ALARMS WERE OBSERVED ON THE ALARM TRACE SUGGESTING POSSIBLE POOR SAMPLE QUALITY. THE CUSTOMER DECLINED A SERVICE VISIT AS THE ISSUE WAS RESOLVED AFTER THEY REMOVED THE CURRENT REAGENT PACK AND RECALIBRATED THE STANDBY REAGENT PACK. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

A COMPLAINT WAS RECEIVED RELATING TO DISCREPANT RESULTS FOR 4 PATIENT SAMPLES TESTED FOR PHOSPHATE (INORGANIC) VER.2 (PHOS2) ON A COBAS 6000 C (501) MODULE. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C502 MODULE SERIAL NUMBER WAS (B)(4).