Description of Event or Problem · 0
THIS EVENT DID NOT OCCUR IN THE USA. WE ARE SUBMITTING THIS REPORT AS THE EVENT OCCURRED AT A HEALTHCARE FACILITY IN DENMARK ON ADEVICE THAT IS SIMILAR TO A DEVICE ALSO MARKETED IN THE USA.ON THE 6TH OF OCTOBER 2022, A CUSTOMER REPORTED TO TBS THAT ON THE 5TH OF OCTOBER 2022, A FALSELY LOW SERUM FREE LIGHT CHAINVALUE (<0.63 MG/L) WAS OBTAINED USING OPTILITE® FREELITE® KAPPA FREE KIT - LK016.10.OPT LOT 509854. THE CUSTOMER ALSOREPORTED ON THE 6TH OF OCTOBER THAT THE SAMPLE WAS RE-RUN WHICH GAVE A VALUE OF >70G/L, SEE SECTION B6. THE CUSTOMER REPORTWAS FOLLOWED UP BY THE BINDING SITE TO DETERMINE IF THERE WAS AN IMPACT ON THE PATIENT AND ON THE 7TH OF OCTOBER 2022, THECUSTOMER INDICATED THAT THERE WAS A 1-DAY DELAY IN TREATING THE PATIENT. THERE IS NO DIRECT INDICATION OF PATIENT HARM AT THIS TIME.THE BINDING SITE'S REVIEW OF THE CUSTOMER'S INSTRUMENT DATABASE RECEIVED ON THE 7TH OCTOBER 2022 INDICATED THE SAMPLEPRESENTED A RESULT <0.63MG/L. THE INITIAL DATA FROM THE ERROR REPORT WOULD SUGGEST THAT THE KAPPA FLC RESULT ON THE 5TH OF OCTOBER2022 WAS IN UNDETECTED AGXS. WHICH LED TO A FALSELY LOW RESULT BEING REPORTED, IN ADDITION THE K/L RATIO WAS REPORTED ASABNORMALLY LOW. PLEASE NOTE, THIS INCIDENT OCCURRED ON LK016.10.OPT LOT 509854, WHICH IS NOT REGISTERED OR SOLD IN THE USA. WE ARE REPORTINGBECAUSE OF THE SIMILAR DEVICES FOR USE ON THE OPTILITE ANALYSER, WHICH ARE REGISTERED AND SOLD IN THE USA : LK016.OPT.A,LK016.10.OPT.A, LK016.M.OPT.AMANUFACTURER SENT IN REPORT ON 01NOV2022.THIS REPORT WAS SENT TO THE FDA 03NOV2022.(NOTE: THIS IS A RESUBMISSION TO CORRECT THE INITIAL MDR REPORT (TITLED: BINDING SITE INC. 3500A 02NOV2022) THAT WAS SENT ON NOV 3RD, 2022. UPON REVIEW (ON JAN 27, 2023) OF THE 3RD ACKNOWLEDGEMENT RECEIPT FOR THE INITIAL SUBMISSION, IT WAS OBSERVED THAT THE 000 ADDED TO THE IMPORTER REPORT NUMBER WAS INPUTTED INCORRECTLY).