ALINITY C IRON2

Description of Event or Problem

THE CUSTOMER REPORTED QC BEING OUT OF RANGE FOR ALINITY C IRON2. THE CUSTOMER FURTHER COMMUNICATED THAT THEY RANDOMLY RETESTED PATIENT SAMPLES OUT OF A TOTAL OF 70 ON ANOTHER ALINITY C PROCESSING MODULE AND NOTED FALSELY ELEVATED RESULTS. THE CUSTOMER WAS NOT ABLE TO PROVIDE PATIENTS¿ AGE AND PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE: 0-14 YEARS: 2.9 -22.9 MOL/L, FEMALE 14 - 19 YEARS: 3.6 - 29.0 MOL/L, MALE 14 - 19 YEARS: 5.5 - 30.1 MOL/L, ADULT FEMALE: 9.0 - 30.4 MOL/L, ADULT MALE: 11.6 - 31.3 MOL/L THE INITIAL RESULT WAS FROM SN: (B)(6) AND REPEAT RESULT WAS FROM SN: (B)(6) SAMPLE INITIAL RESULT WAS 64.2, REPEAT RESULT WAS 52.5. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENTS¿ MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION REGARDING QUALITY CONTROL BEING OUT OF RANGE, WHICH CAME BACK IN RANGE AFTER RECALIBRATION WITH FALSELY ELEVATED ALINITY C IRON2 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET AND TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. IN HOUSE TESTING WAS PERFORMED WITH FOR CALIBRATION STABILITY WITH REAGENT AND CALIBRATION USED BY THE CUSTOMER, WHICH WAS ALINITY C IRON2 REAGENT LOT 51379UD00 AND CALIBRATOR CONCC LOT: 0001230UE. TESTING MET ALL VALIDITY AND ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C IRON2 REAGENT LOT 51379UD00.THE FOLLOWING FIELDS WERE CORRECTED.

Additional Manufacturer Narrative

ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED QC BEING OUT OF RANGE FOR SALINITY CIRON 2. THE CUSTOMER FURTHER COMMUNICATED THAT THEY RANDOMLY RETESTED PATIENT SAMPLES OUT OF A TOTAL OF 70 ON ANOTHER ALINITY C PROCESSING MODULE AND NOTED FALSELY ELEVATED RESULTS. THE CUSTOMER WAS NOT ABLE TO PROVIDE PATIENTS¿ AGE AND PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE: 0-14 YEARS: 2.9 -22.9 ¿MOL/L, FEMALE 14 - 19 YEARS: 3.6 - 29.0 ¿MOL/L, MALE 14 - 19 YEARS: 5.5 - 30.1 ¿MOL/L, ADULT FEMALE: 9.0 - 30.4 ¿MOL/L, ADULT MALE: 11.6 - 31.3 ¿MOL/L THE INITIAL RESULT WAS FROM SN: AC02838 AND REPEAT RESULT WAS FROM SN: AC04137 SAMPLE INITIAL RESULT WAS 64.2, REPEAT RESULT WAS 52.5. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENTS¿ MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.