ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION REGARDING FALSE REACTIVE ALINITY I CMV IGG REAGENT LOT NUMBER 47298FN00 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. TICKET SEARCH BY LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. TICKET AND TRENDING REVIEW FOR THE ALINITY I CMV IGG REAGENT DID NOT IDENTIFY ANY RELATED TRENDS REGARDING COMMONALITIES FOR LOT NUMBER AND COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 47298FN00 AND THE COMPLAINT ISSUE. IN HOUSE TESTING WAS CONDUCTED ON LOT NUMBER 47298FN00, AND THE TESTING DETERMINED THE SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A LABELING REVIEW DETERMINED PRODUCT LABELING PROVIDES ADEQUATE INFORMATION REGARDING THE CUSTOMER ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CMV IGG REAGENT LOT NUMBER 47298FN00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE RESULT OF ALINITY I CMV IGG FOR 1 PREGNANT FEMALE PATIENT WITH NO PAST RESULTS FOR CMV IGG AND PROVIDED THE FOLLOWING DATA: (REFERENCE: = 6.0 AU/ML IS REACTIVE) CMV IGG INITIAL RESULT WAS 113.10 (REACTIVE). THE CUSTOMER REPEATED THE TEST BUT DID NOT PROVIDE OBJECTIVE VALUES. THE SAMPLE WAS REPEATED ON THE VIDAS PLATFORM, WHICH GENERATED A RESULT OF 5 (NEGATIVE). ADDITIONAL LABORATORY TESTING PROVIDED BY THE CUSTOMER: THE PATIENT WAS NON-REACTIVE FOR CMV IGM, POSITIVE FOR VZV-IGG. THE CUSTOMER REPORTED THAT THE DISCREPANT RESULTS WERE NOT RELEASED TO THE PATIENT¿S MEDICAL PROVIDER AND THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42-22/-32 AND THERE IS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE RESULT OF ALINITY I CMV IGG FOR 1 PREGNANT FEMALE PATIENT WITH NO PAST RESULTS FOR CMV IGG AND PROVIDED THE FOLLOWING DATA: (REFERENCE: = 6.0 AU/ML IS REACTIVE). CMV IGG INITIAL RESULT WAS 113.10 (REACTIVE). THE CUSTOMER REPEATED THE TEST BUT DID NOT PROVIDE OBJECTIVE VALUES. THE SAMPLE WAS REPEATED ON THE VIDAS PLATFORM, WHICH GENERATED A RESULT OF 5 (NEGATIVE). ADDITIONAL LABORATORY TESTING PROVIDED BY THE CUSTOMER: THE PATIENT WAS NON-REACTIVE FOR CMV IGM, POSITIVE FOR VZV-IGG. THE CUSTOMER REPORTED THAT THE DISCREPANT RESULTS WERE NOT RELEASED TO THE PATIENT¿S MEDICAL PROVIDER AND THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.