ALINITY S CHAGAS
Received Dec 9, 2019
Report 3002809144-2019-01044 · MDR key 9437641
Device
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING SUBMITTED ON AN INTERNATIONAL PRODUCT, ALINITY CHAGAS LN 06P08-45, WHICH HAS A SIMILAR PRODUCT IN THE US, LN 06P08-50.
Description of Event or Problem
THE CUSTOMER OBSERVED AN INCREASE IN FALSELY ELEVATED CHAGAS RESULTS ON THE ALINITY S ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 6.364, REPEAT 2.428. SID (B)(6) INITIAL 1.358, REPEAT 1.362. SID (B)(6) INITIAL 0.928, REPEAT 1.162. THE SAMPLES WERE CONFIRMED NEGATIVE ON ANOTHER ANALYZER: SID (B)(6) INITIAL 0.013, REPEATS 0.013, 0.03. SID (B)(6) INITIAL 0.019, REPEATS 0.027, 0.06. SID (B)(6) INITIAL 0.028, REPEATS 0.029, 0.04. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
AN INVESTIGATION WAS PERFORMED AND IDENTIFIED A DEFICIENCY FOR ALINITY S CHAGAS, LIST NUMBER 06P08-45, LOT NUMBER 01166BE00. AN INCREASE IN COMPLAINT ACTIVITY RESULTED IN IDENTIFYING A PRODUCT DEFICIENCY OF CERTAIN LOTS OF ALINITY S CHAGAS. HOWEVER, THE INVESTIGATION DETERMINED THAT THE IMPACTED LOTS WERE NOT DISTRIBUTED IN THE US, AND THEREFORE NO FURTHER ACTION IN THE US IS WARRANTED.