CD19 PE-CY7 CE

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH CD19 PE-CY7 CE ERRONEOUS RESULTS WERE OBTAINED. RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 341113, CD19PE-CY7 APPEARS TO BE NON-FUNCTIONAL 1.WERE PATIENT SAMPLES INVOLVED? THE PRODUCT WAS USED ON A SAMPLE FROM A PATIENT. 2.WAS IT OBVIOUS THAT THE RESULTS WERE INCORRECT/COULD NOT BE CONSIDERED RELIABLE? IT WAS EVIDENT THAT THE RESULTS WERE INCORRECT AND COULD NOT BE CONSIDERED RELIABLE. 3.IS A CONFIRMATORY TEST ALWAYS PERFORMED? WE PERFORMED A REPEAT WITH THE SAME PRODUCT AND REPEATED WITH A DIFFERENT ONE. 4.HAVE THE INCORRECT RESULTS BEEN COMMUNICATED TO THE DOCTOR? INCORRECT RESULTS HAVE NOT BEEN COMMUNICATED TO THE DOCTOR.

Additional Manufacturer Narrative

G.5. THE EVENT DESCRIBED OCCURRED ON AN ASR CE MARKED REAGENT, HOWEVER, IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED REAGENT (341103). THE US REAGENT 510K (EXEMPT) HAS BEEN REPORTED. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH CD19 PE-CY7 CE ERRONEOUS RESULTS WERE OBTAINED. RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 341113 CD19PE-CY7 APPEARS TO BE NON-FUNCTIONAL. 1.WERE PATIENT SAMPLES INVOLVED? THE PRODUCT WAS USED ON A SAMPLE FROM A PATIENT 2.WAS IT OBVIOUS THAT THE RESULTS WERE INCORRECT/COULD NOT BE CONSIDERED RELIABLE? IT WAS EVIDENT THAT THE RESULTS WERE INCORRECT AND COULD NOT BE CONSIDERED RELIABLE 3.IS A CONFIRMATORY TEST ALWAYS PERFORMED? WE PERFORMED A REPEAT WITH THE SAME PRODUCT AND REPEATED WITH A DIFFERENT ONE . 4.HAVE THE INCORRECT RESULTS BEEN COMMUNICATED TO THE DOCTOR? INCORRECT RESULTS HAVE NOT BEEN COMMUNICATED TO THE DOCTOR.

Additional Manufacturer Narrative

H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED PERFORMANCE ISSUE AGAINST PRODUCT 341113 (CD19 PE-CY7) LOT 3163258 WAS NOT CONFIRMED. CUSTOMER DID NOT ANSWER SPECIFIC QUESTIONS OR PROVIDE ADDITIONAL INFORMATION REQUESTED AIMED TO UNDERSTAND REPORTED PROBLEM AND DETERMINE POSSIBLE CAUSE(S), HENCE A POSSIBLE CAUSE FOR REPORTED PROBLEM COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.