ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P67-22 / 32 / 74 / 77 AND THERE IS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 / 31. 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 ISSUES WITH CONTROLS BEING OUT OF RANGE AND ALSO REPORTED INCONSISTENT ALINITY I B12 RESULTS. THE CUSTOMER IS NOT CERTAIN WHICH RESULTS ARE THE CORRECT RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA AFTER THE REGENT WAS RECALIBRATED: CUSTOMER NORMAL RANGE IS > 200 PG/ML SAMPLE ID (B)(6) RESULT FROM 12 JULY WAS <148, RESULT FROM 12 JULY IN THE AFTERNOON WAS 183, AND RESULT FROM 13 JULY WAS 361 SAMPLE ID (B)(6) RESULT FROM 12 JULY WAS <148, RESULT FROM 12 JULY IN THE AFTERNOON WAS 155, AND RESULT FROM 13 JULY WAS 349 SAMPLE ID (B)(6) RESULT FROM 12 JULY WAS 152, RESULT FROM 12 JULY IN THE AFTERNOON WAS 181, AND RESULT FROM 13 JULY WAS 359 SAMPLE ID (B)(6) RESULT FROM 12 JULY WAS 171, RESULT FROM 12 JULY IN THE AFTERNOON WAS 164, AND RESULT FROM 13 JULY WAS 543 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION 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 DID NOT IDENTIFY AN INCREASE COMPLAINT ACTIVITY FOR THE COMPLAINT LOT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALITIES FOR COMPLAINT ISSUE AND LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. IN-HOUSE TESTING WAS PERFORMED FOR 51430UD00, WHICH MET ACCEPTANCE AND VALIDITY CRITERIA FOR ABBOTT CONTROLS AND SUGGESTS THAT THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I B12 REAGENT LOT 51430UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED ISSUES WITH CONTROLS BEING OUT OF RANGE AND ALSO REPORTED INCONSISTENT ALINITY I B12 RESULTS. THE CUSTOMER IS NOT CERTAIN WHICH RESULTS ARE THE CORRECT RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA AFTER THE REGENT WAS RECALIBRATED: CUSTOMER NORMAL RANGE IS > 200 PG/ML SAMPLE ID (B)(6) RESULT FROM 12 JULY WAS <148, RESULT FROM 12 JULY IN THE AFTERNOON WAS 183, AND RESULT FROM 13 JULY WAS 361. SAMPLE ID (B)(6) RESULT FROM 12 JULY WAS <148, RESULT FROM 12 JULY IN THE AFTERNOON WAS 155, AND RESULT FROM 13 JULY WAS 349. SAMPLE ID (B)(6) RESULT FROM 12 JULY WAS 152, RESULT FROM 12 JULY IN THE AFTERNOON WAS 181, AND RESULT FROM 13 JULY WAS 359. SAMPLE ID (B)(6) RESULT FROM 12 JULY WAS 171, RESULT FROM 12 JULY IN THE AFTERNOON WAS 164, AND RESULT FROM 13 JULY WAS 543. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.